HIV PreventionNCT04048551
The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
A study testing Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum and Young Women's Health CoOp (YWHC) in people with HIV Prevention, run by RTI International at 1 site in South Africa.
Trial summary
The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to the HIV prevention plan for the Government of South Africa. Read more about this study
- Who is it for?
- Ages 16 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum and Young Women's Health CoOp (YWHC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteSouth Africa
- Study dates
- 4 Apr 2019to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV negative
- identify as female;
- aged 16-24;
- have had condomless sex in the past 3 months with a male partner;
- not be currently pregnant and not want to get pregnant for the next year;
- interested in taking PrEP;
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- not having previously participated in the formative phase of the study;
- have not previously and not currently participating in any other PrEP-related demonstration project or research study;
- not previously or not currently participating in any other HIV study in Tshwane;
- lives in one of the target communities;
- not on multidrug-resistant tuberculosis (MDR-TB) treatment;
- intends to stay in the Tshwane district for the next 12 months;
- agrees to provide contact information;
- be willing to undergo rapid HIV testing;
- be willing to undergo pregnancy testing.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to the HIV prevention plan for the Government of South Africa. Specifically, this project aims to: increase uptake, of sexual and reproductive health (SRH) services and readiness and uptake of PrEP among adolescent girls and young women (AGYW) aged 16 to 24 who engage in high-risk sexual behaviors; and reduce their barriers to accessing SRH services by addressing and reducing stigma and discrimination (S\&D) in clinics.
Read the detailed description
The researchers propose a cluster randomized trial with a factorial design to evaluate the efficacy of a multi-level intervention that addresses stigma in accessing healthcare, social support, and individual risk behaviors of adolescent girls and young women (AGYW) in South Africa. The researchers engaged stakeholders from the Department of Health, a Community Collaborative Board (CCB), and a Youth Advisory Board (YAB) to inform the adaptation of the evidence-based empowerment intervention, the Women's Health CoOp (WHC)-which addresses gender-based violence (GBV), substance use, and sexual risk-to address sexual and reproductive health (SRH) and pre-exposure prophylaxis (PrEP) readiness, uptake and adherence. Through engagement with stakeholders, the researchers also adapted a stigma and discrimination (S\&D) reduction training curriculum for clinic staff.
The project plans to increase uptake of SRH services, and PrEP readiness, uptake and adherence among AGYW aged 16 to 24 who engage in high-risk sex. The investigators plan to conduct this through a multilevel HIV prevention strategy that addresses S\&D in AGYW accessing healthcare, social support, and individual risk behaviors. This cluster randomized trial with a factorial design will be conducted across 12 clinics in Pretoria.
The aims of this study are (1) To engage stakeholders, the Community Collaborative Board (CCB), and the Youth Advisory Board (YAB) in adapting the Women's Health CoOp (WHC) and stigma and discrimination (S\&D) reduction training, in the Pretoria area during a formative stage.
(2) To evaluate the impact of training on S\&D among healthcare staff on the use of HIV and reproductive health services by adolescent girls and young women (AGYW), including pre-exposure prophylaxis (PrEP), and staff attitudes and behaviors toward AGYW at 4- and 8-month follow-up.
(3) To test the efficacy of a multilevel strategy that addresses structural (stigma and discrimination), interpersonal (social support), and individual (personal agency, substance use, and gender-based violence [GBV]) factors on PrEP readiness and uptake, and adherence (primary outcomes) and condom use, GBV, substance use, and HIV incidence (secondary) at 3-, 6-, and 9-month follow-up among vulnerable AGYW.
- Conditions
- HIV Prevention
- Being tested
- Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum, Young Women's Health CoOp (YWHC)
- Keywords
- PrEP (Pre-exposure Prophylaxis), HIV (Human Immunodeficiency Virus), Adolescent Girls and Young Women (AGYW), Stigma and Discrimination (S&D), Gender-based violence (GBV), Substance use
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumBehavioural
The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW.
Young Women's Health CoOp (YWHC)Behavioural
In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence.
| Study group | Role | What they receive |
|---|---|---|
| No S&D Reduction Training; PrEP and SRH only | No intervention | Arm 1 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women). |
| No S&D Reduction Training; PrEP and SRH + YWHC | Experimental | Arm 2 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women). Receives: Behavioral: Young Women's Health CoOp (YWHC) |
| S&D Reduction Training; PrEP and SRH only | Active comparator | Arm 3 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women). Receives: Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum |
| S&D Reduction Training; PrEP, SRH + YWHC | Experimental | Arm 4 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women). Receives: Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum; Behavioral: Young Women's Health CoOp (YWHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Measured: Baseline
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Measured: 4 months
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Measured: 8 months
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
Measured: Baseline
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
Measured: 4 months
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
Measured: 8 months
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures developed for this study and from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
Measured: Baseline
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
Measured: 3 months
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
Measured: 6 months
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
Measured: 9 months
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
Measured: 3 months
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
Measured: 6 months
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
Measured: 9 months
AGYW Biological Outcome: Adherence to PrEP
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
Measured: 3 months
AGYW Biological Outcome: Adherence to PrEP
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
Measured: 6 months
AGYW Biological Outcome: Adherence to PrEP
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
Measured: 9 months
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
Measured: 3 months
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
Measured: 6 months
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
Measured: 9 months
Secondary outcomes (53)
AGYW Participant Self-Report: Frequency of Drug Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of drug (e.g, methamphetamine) use and injecting.
Measured: Baseline
AGYW Participant Self-Report: Frequency of Drug Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of drug (e.g, methamphetamine) use and injecting.
Measured: 3 months
AGYW Participant Self-Report: Frequency of Drug Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of drug (e.g, methamphetamine) use and injecting..
Measured: 6 months
AGYW Participant Self-Report: Frequency of Drug Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of drug (e.g, methamphetamine) use and injecting.
Measured: 9 months
AGYW Participant Self-Report: Frequency of Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of days of alcohol consumption and the number of days of problematic (4+) alcohol consumption.
Measured: Baseline
AGYW Participant Self-Report: Frequency of Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of days of alcohol consumption and the number of days of problematic (4+) alcohol consumption
Measured: 3 months
AGYW Participant Self-Report: Frequency of Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of days of alcohol consumption and the number of days of problematic (4+) alcohol consumption
Measured: 6 months
AGYW Participant Self-Report: Frequency of Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of days of alcohol consumption and the number of days of problematic (4+) alcohol consumption.
Measured: 9 months
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of combining drugs with alcohol.
Measured: baseline
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of combining drugs with alcohol.
Measured: 3 months
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of combining drugs with alcohol.
Measured: 6 Months
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of combining drugs with alcohol.
Measured: 9 months
AGYW Participant Self-Report: Frequency of Condom Use
Self-report responses on single-item questions will be used to assess condom use. Condom use will be calculated as a count and percentage (based on the total number of acts and the numbers of acts with a condom). Lower percentage values indicate less frequent condom use. For the count variable, greater values indicate more acts of sex without a condom.
Measured: Baseline
AGYW Participant Self-Report: Frequency of Condom Use
Self-report responses on single-item questions will be used to assess condom use. Condom use will be calculated as a count and percentage (based on the total number of acts and the numbers of acts with a condom). Lower percentage values indicate less frequent condom use. For the count variable, greater values indicate more acts of sex without a condom.
Measured: 3 months
AGYW Participant Self-Report: Frequency of Condom Use
Self-report responses on single-item questions will be used to assess condom use. Condom use will be calculated as a count and percentage (based on the total number of acts and the numbers of acts with a condom). Lower percentage values indicate less frequent condom use. For the count variable, greater values indicate more acts of sex without a condom.
Measured: 6 months
AGYW Participant Self-Report: Frequency of Condom Use
Self-report responses on single-item questions will be used to assess condom use. Condom use will be calculated as a count and percentage (based on the total number of acts and the numbers of acts with a condom). Lower percentage values indicate less frequent condom use. For the count variable, greater values indicate more acts of sex without a condom.
Measured: 9 months
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Self-report responses on single-item questions from the Pretoria Risk Behavior Assessment will be used to assess engagement in alcohol and other drug use prior to or during sex.
Measured: Baseline
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Self-report responses on single-item questions from the Pretoria Risk Behavior Assessment will be used to assess engagement in alcohol and other drug use prior to or during sex.
Measured: 3 months
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Self-report responses on single-item questions from the Pretoria Risk Behavior Assessment will be used to assess engagement in alcohol and other drug use prior to or during sex.
Measured: 6 months
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Self-report responses on single-item questions from the Pretoria Risk Behavior Assessment will be used to assess engagement in alcohol and other drug use prior to or during sex.
Measured: 9 months
AGYW Participant Self-Report: Number of Other Sex Partners
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of other sex partners among AGYW.
Measured: Baseline
AGYW Participant Self-Report: Number of Other Sex Partners
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of other sex partners among AGYW.
Measured: 3 months
AGYW Participant Self-Report: Number of Other Sex Partners
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of other sex partners among AGYW.
Measured: 6 months
AGYW Participant Self-Report: Number of Other Sex Partners
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the number of other sex partners among AGYW.
Measured: 9 months
AGYW Participant Self-Report: Engagement in Sex Trading
Self-report responses on single-item measures modified from the Pretoria Risk Behavior Assessment (PRBA) will be used to assess whether participants engaged in trading sex for money or other things.
Measured: Baseline
AGYW Participant Self-Report: Engagement in Sex Trading
Self-report responses on single-item measures modified from the Pretoria Risk Behavior Assessment (PRBA) will be used to assess whether participants engaged in trading sex for money or other things.
Measured: 3 months
AGYW Participant Self-Report: Engagement in Sex Trading
Self-report responses on single-item measures modified from the Pretoria Risk Behavior Assessment (PRBA) will be used to assess whether participants engaged in trading sex for money or other things.
Measured: 6 months
AGYW Participant Self-Report: Engagement in Sex Trading
Self-report responses on single-item measures modified from the Pretoria Risk Behavior Assessment (PRBA) will be used to assess whether participants engaged in trading sex for money or other things.
Measured: 9 months
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess engagement with more than one sex partner in the past 3 months.
Measured: Baseline
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess engagement with more than one sex partner in the past 3 months.
Measured: 3 months
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess engagement with more than one sex partner in the past 3 months.
Measured: 6months
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess engagement with more than one sex partner in the past 3 months.
Measured: 9 months
AGYW Participant Self-Report: Use of Contraception
Self-report responses on single-item measures will be used to assess use of contraception and types of contraception among AGYW.
Measured: Baseline
AGYW Participant Self-Report: Use of Contraception
Self-report responses on single-item measures will be used to assess use of contraception and types of contraception among AGYW.
Measured: 3 months
AGYW Participant Self-Report: Use of Contraception
Self-report responses on single-item measures will be used to assess use of contraception and types of contraception among AGYW.
Measured: 6 months
AGYW Participant Self-Report: Use of Contraception
Self-report responses on single-item measures will be used to assess use of contraception and types of contraception among AGYW.
Measured: 9 months
Medical Record: Use of Contraception
Clinical medical record will be used to assess contraception and contraception type among AGYW.
Measured: Through study completion, an average of nine months
AGYW Participant Self-Report: Level of Perception of HIV Risk
Self-report responses on single-item questions will be used to assess the extent to which AGYW perceive themselves as at risk for HIV infection. Higher levels indicate greater perceived HIV risk.
Measured: Baseline
AGYW Participant Self-Report: Level of Perception of HIV Risk
Self-report responses on single-item questions will be used to assess the extent to which AGYW perceive themselves as at risk for HIV infection. Higher levels indicate greater perceived HIV risk.
Measured: 3 months
AGYW Participant Self-Report: Level of Perception of HIV Risk
Self-report responses on single-item questions will be used to assess the extent to which AGYW perceive themselves as at risk for HIV infection. Higher levels indicate greater perceived HIV risk.
Measured: 6 months
AGYW Participant Self- Report; Level of Perception of HIV Risk
Self-report responses on single-item questions will be used to assess the extent to which AGYW perceive themselves as at risk for HIV infection. Higher levels indicate greater perceived HIV risk.
Measured: 9 months
AGYW Participant Self-Report: The Frequency of Experienced Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of experiencing stigma or discrimination from clinic staff or community members among AGYW.
.
Measured: Baseline
AGYW Participant Self-Report: The Frequency of Experienced Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of experiencing stigma or discrimination from clinic staff or community members among AGYW.
.
Measured: 3 months
AGYW Participant Self-Report: The Frequency of Experienced Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of experiencing stigma or discrimination from clinic staff or community members among AGYW.
Measured: 6 months
AGYW Participant Self-Report: The Frequency of Experienced Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess the frequency of experiencing stigma or discrimination from clinic staff or community members among AGYW.
Measured: 9 months
AGYW Participant Self-Report: The Level of Anticipated Stigma
Self-report responses on single-item questions and multiple-item scales developed from the formative research study activities will be used to assess the extent to which AGYW anticipate stigma or discrimination from clinic staff or community members. Higher values indicate greater levels of anticipated stigma.
Measured: Baseline
AGYW Participant Self-Report: The Level of Anticipated Stigma
Self-report responses on single-item questions and multiple-item scales developed from the formative research study activities will be used to assess the extent to which AGYW anticipate stigma or discrimination from clinic staff or community members. Higher values indicate greater levels of anticipated stigma.
Measured: 3 months
AGYW Participant Self-Report: The Level of Anticipated Stigma
Self-report responses on single-item questions and multiple-item scales developed from the formative research study activities will be used to assess the extent to which AGYW anticipate stigma or discrimination from clinic staff or community members. Higher values indicate greater levels of anticipated stigma.
Measured: 6 months
AGYW Participant Self-Report: The Level of Anticipated Stigma
Self-report responses on single-item questions and multiple-item scales developed from the formative research study activities will be used to assess the extent to which AGYW anticipate stigma or discrimination from clinic staff or community members. Higher values indicate greater levels of anticipated stigma.
.
Measured: 9 months
AGYW Participant Self-Report: The Frequency of Observed Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to the assess the frequency that AGYW have witnessed stigma or discrimination from clinic staff or community members toward sexually active AGYW.
Measured: Baseline
AGYW Participant Self-Report: The Frequency of Observed Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to the assess the frequency that AGYW have witnessed stigma or discrimination from clinic staff or community members toward sexually active AGYW.
Measured: 3 months
AGYW Participant Self-Report: The Frequency of Observed Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to the assess the frequency that AGYW have witnessed stigma or discrimination from clinic staff or community members toward sexually active AGYW.
Measured: 6 months
AGYW Participant Self-Report: The Frequency of Observed Stigma
Self-report responses on the AGYW questionnaire adapted from previous research will be used to the assess the frequency that AGYW have witnessed stigma or discrimination from clinic staff or community members toward sexually active AGYW.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start4 Apr 2019
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a cluster randomized trial that utilizes a 2 x 2 factorial design to assess the impact of S\&D reduction training and the YWHC intervention, resulting in four study conditions: (1) Clinic S\&D reduction training + PrEP/SRH + YWHC, (2) Clinic S\&D reduction training + PrEP/SRH only, (3) No Clinic S\&D reduction training +PrEP/SRH + YWHC, (4) No Clinic S\&D reduction training + PrEP/SRH only. The researchers will examine two primary endpoints: (1) the proportion of AGYW who are ready to uptake and initiate PrEP and SRH services; and, (2) the differences in levels of PrEP adherence between each intervention condition and the standard of care comparison at 3-, 6- and 9-month follow-up.
- Masking
- None (open label)
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Setshaba Research Centre
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048551
- Sponsor's protocol ID
- R01HD094629
- Status last verified
- Jan 2025
- First submitted
- 28 May 2019
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Minnis AM, Nyblade L, Speizer IS, Howard BN, Myers B, Ahmed K. The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa. BMC Public Health. 2020 Sep 15;20(1):1403. doi: 10.1186/s12889-020-09458-y.
PubMed 32933510
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
- ClinicalTrials.gov ID
- NCT04048551
- Acronym / sponsor ID
- R01HD094629
- Conditions
- HIV Prevention
- Keywords
- PrEP (Pre-exposure Prophylaxis), HIV (Human Immunodeficiency Virus), Adolescent Girls and Young Women (AGYW), Stigma and Discrimination (S&D), Gender-based violence (GBV), Substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Setshaba Research Centre
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to the HIV prevention plan for the Government of South Africa. Specifically, this project aims to: increase uptake, of sexual and reproductive health (SRH) services and readiness and uptake of PrEP among adolescent girls and young women (AGYW) aged 16 to 24 who engage in high-risk sexual behaviors; and reduce their barriers to accessing SRH services by addressing and reducing stigma and discrimination (S\&D) in clinics.
Detailed description
The researchers propose a cluster randomized trial with a factorial design to evaluate the efficacy of a multi-level intervention that addresses stigma in accessing healthcare, social support, and individual risk behaviors of adolescent girls and young women (AGYW) in South Africa. The researchers engaged stakeholders from the Department of Health, a Community Collaborative Board (CCB), and a Youth Advisory Board (YAB) to inform the adaptation of the evidence-based empowerment intervention, the Women's Health CoOp (WHC)-which addresses gender-based violence (GBV), substance use, and sexual risk-to address sexual and reproductive health (SRH) and pre-exposure prophylaxis (PrEP) readiness, uptake and adherence. Through engagement with stakeholders, the researchers also adapted a stigma and discrimination (S\&D) reduction training curriculum for clinic staff.
The project plans to increase uptake of SRH services, and PrEP readiness, uptake and adherence among AGYW aged 16 to 24 who engage in high-risk sex. The investigators plan to conduct this through a multilevel HIV prevention strategy that addresses S\&D in AGYW accessing healthcare, social support, and individual risk behaviors. This cluster randomized trial with a factorial design will be conducted across 12 clinics in Pretoria.
The aims of this study are (1) To engage stakeholders, the Community Collaborative Board (CCB), and the Youth Advisory Board (YAB) in adapting the Women's Health CoOp (WHC) and stigma and discrimination (S\&D) reduction training, in the Pretoria area during a formative stage.
(2) To evaluate the impact of training on S\&D among healthcare staff on the use of HIV and reproductive health services by adolescent girls and young women (AGYW), including pre-exposure prophylaxis (PrEP), and staff attitudes and behaviors toward AGYW at 4- and 8-month follow-up.
(3) To test the efficacy of a multilevel strategy that addresses structural (stigma and discrimination), interpersonal (social support), and individual (personal agency, substance use, and gender-based violence [GBV]) factors on PrEP readiness and uptake, and adherence (primary outcomes) and condom use, GBV, substance use, and HIV incidence (secondary) at 3-, 6-, and 9-month follow-up among vulnerable AGYW.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a cluster randomized trial that utilizes a 2 x 2 factorial design to assess the impact of S\&D reduction training and the YWHC intervention, resulting in four study conditions: (1) Clinic S\&D reduction training + PrEP/SRH + YWHC, (2) Clinic S\&D reduction training + PrEP/SRH only, (3) No Clinic S\&D reduction training +PrEP/SRH + YWHC, (4) No Clinic S\&D reduction training + PrEP/SRH only. The researchers will examine two primary endpoints: (1) the proportion of AGYW who are ready to uptake and initiate PrEP and SRH services; and, (2) the differences in levels of PrEP adherence between each intervention condition and the standard of care comparison at 3-, 6- and 9-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| No S&D Reduction Training; PrEP and SRH only | No intervention | –Arm 1 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women). |
| No S&D Reduction Training; PrEP and SRH + YWHC | Experimental | Behavioral: Young Women's Health CoOp (YWHC)Arm 2 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women). |
| S&D Reduction Training; PrEP and SRH only | Active comparator | Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumArm 3 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women). |
| S&D Reduction Training; PrEP, SRH + YWHC | Experimental | Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum, Behavioral: Young Women's Health CoOp (YWHC)Arm 4 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women). |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- HIV negative
- identify as female;
- aged 16-24;
- have had condomless sex in the past 3 months with a male partner;
- not be currently pregnant and not want to get pregnant for the next year;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumThe Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW. | Behavioural | S&D Reduction Training; PrEP and SRH only, S&D Reduction Training; PrEP, SRH + YWHC |
| Young Women's Health CoOp (YWHC)In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence. | Behavioural | No S&D Reduction Training; PrEP and SRH + YWHC, S&D Reduction Training; PrEP, SRH + YWHC |
Primary outcome
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
Time frame: Baseline
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
Time frame: 4 months
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
Time frame: 8 months
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
Time frame: Baseline
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
Time frame: 4 months
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
Time frame: 8 months
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Time frame: Baseline
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures developed for this study and from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Time frame: 3 months
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Time frame: 6 months
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
Time frame: 9 months
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
Time frame: 3 months
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
Time frame: 6 months
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
Time frame: 9 months
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
AGYW Biological Outcome: Adherence to PrEP
Time frame: 3 months
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
AGYW Biological Outcome: Adherence to PrEP
Time frame: 6 months
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
AGYW Biological Outcome: Adherence to PrEP
Time frame: 9 months
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
Time frame: 3 months
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
Time frame: 6 months
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
Time frame: 9 months
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
53 secondary outcomes
AGYW Participant Self-Report: Frequency of Drug Use
Time frame: Baseline
AGYW Participant Self-Report: Frequency of Drug Use
Time frame: 3 months
AGYW Participant Self-Report: Frequency of Drug Use
Time frame: 6 months
AGYW Participant Self-Report: Frequency of Drug Use
Time frame: 9 months
AGYW Participant Self-Report: Frequency of Alcohol Use
Time frame: Baseline
AGYW Participant Self-Report: Frequency of Alcohol Use
Time frame: 3 months
AGYW Participant Self-Report: Frequency of Alcohol Use
Time frame: 6 months
AGYW Participant Self-Report: Frequency of Alcohol Use
Time frame: 9 months
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Time frame: baseline
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Time frame: 3 months
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Time frame: 6 Months
AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
Time frame: 9 months
AGYW Participant Self-Report: Frequency of Condom Use
Time frame: Baseline
AGYW Participant Self-Report: Frequency of Condom Use
Time frame: 3 months
AGYW Participant Self-Report: Frequency of Condom Use
Time frame: 6 months
AGYW Participant Self-Report: Frequency of Condom Use
Time frame: 9 months
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Time frame: Baseline
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Time frame: 3 months
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Time frame: 6 months
AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
Time frame: 9 months
AGYW Participant Self-Report: Number of Other Sex Partners
Time frame: Baseline
AGYW Participant Self-Report: Number of Other Sex Partners
Time frame: 3 months
AGYW Participant Self-Report: Number of Other Sex Partners
Time frame: 6 months
AGYW Participant Self-Report: Number of Other Sex Partners
Time frame: 9 months
AGYW Participant Self-Report: Engagement in Sex Trading
Time frame: Baseline
AGYW Participant Self-Report: Engagement in Sex Trading
Time frame: 3 months
AGYW Participant Self-Report: Engagement in Sex Trading
Time frame: 6 months
AGYW Participant Self-Report: Engagement in Sex Trading
Time frame: 9 months
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Time frame: Baseline
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Time frame: 3 months
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Time frame: 6months
AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
Time frame: 9 months
AGYW Participant Self-Report: Use of Contraception
Time frame: Baseline
AGYW Participant Self-Report: Use of Contraception
Time frame: 3 months
AGYW Participant Self-Report: Use of Contraception
Time frame: 6 months
AGYW Participant Self-Report: Use of Contraception
Time frame: 9 months
Medical Record: Use of Contraception
Time frame: Through study completion, an average of nine months
AGYW Participant Self-Report: Level of Perception of HIV Risk
Time frame: Baseline
AGYW Participant Self-Report: Level of Perception of HIV Risk
Time frame: 3 months
AGYW Participant Self-Report: Level of Perception of HIV Risk
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 32933510Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Minnis AM, Nyblade L, Speizer IS, Howard BN, Myers B, Ahmed K. The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa. BMC Public Health. 2020 Sep 15;20(1):1403. doi: 10.1186/s12889-020-09458-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicia Browne, ScD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum and Young Women's Health CoOp (YWHC) in people with HIV Prevention, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination (time frame: Baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.