HIVNCT06835751
Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania
A study testing Motivational Interviewing for PreP and Common Elements Treatment Approach (CETA) + MI-PrEP in people with HIV and Mental Health, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Tanzania.
Trial summary
This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Mental Health, Substance Use (Drugs, Alcohol)
- What is being tested?
- Motivational Interviewing for PreP and Common Elements Treatment Approach (CETA) + MI-PrEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteTanzania
- Study dates
- 25 Jul 2025to 9 Oct 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- 18 years or older
- Non-reactive or negative HIV test result
- Self-reported drug- or sex-related HIV risk behaviors in the past six months
- Hazardous or harmful opioid use in the past six months
- Meets criteria for at least one of the following co-occurring mental health conditions: symptoms of depression (PHQ-9 >= 9), anxiety (GAD-7 >= 10), and/or PTSD (HTQ >= 40)
Who cannot join
- Reactive or positive HIV test result
- Currently taking PrEP
- Actively suicidal, homicidal, or psychotic, and needing immediate hospitalization based on safety assessments
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Official title: Optimizing PrEP Among Women Who Use Drugs in Tanzania
This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support.
The study will enroll 200 women who use drugs in Dar es Salaam, Tanzania. These women will be randomly assigned to one of three groups:
Read more
Motivational Interviewing for PrEP (MI-PrEP) Only - Women in this group will receive two one-hour counseling sessions focused on HIV prevention, PrEP education, and problem-solving to help the women start and continue using PrEP.
Common Elements Treatment Approach (CETA) + MI-PrEP - Women in this group will receive the same MI-PrEP counseling sessions plus additional mental health counseling (up to 14 sessions) tailored to the women's individual needs, addressing issues like depression, anxiety, trauma, and substance use.
Treatment as Usual (TAU) - Women in this group will receive basic information on PrEP, mental health, and harm reduction, along with optional referrals to PrEP or drug treatment clinics.
The study will evaluate feasibility of administering MI-PrEP and CETA+MI-PrEP and how well these interventions help women start and stay on PrEP, as well as the intervention's impact on mental health and drug use. Researchers will also interview participants and counselors to understand the participants and counselors experiences with the program.
The goal is to find effective ways to support PrEP use among women who use drugs and to develop a model that could be used in similar settings to reduce HIV risk. This pilot study is approved by ethics committees in the United States and Tanzania, and results will be shared with communities, policymakers, and researchers.
Read the detailed description
This study is a pilot clinical trial aiming to assess the feasibility and preliminary efficacy of two interventions designed to improve PrEP engagement among women who use drugs (WWUD) in Dar es Salaam, Tanzania. The trial will enroll 200 participants who will be randomly assigned to one of three study arms: Motivational Interviewing for PrEP (MI-PrEP) only, Common Elements Treatment Approach (CETA) + MI-PrEP, or Enhanced Treatment as Usual (TAU). The study will evaluate whether these interventions can enhance PrEP uptake and adherence, while also addressing mental health and substance use challenges common among WWUD.
WWUD in Tanzania are at a heightened risk of acquiring HIV due to intersecting vulnerabilities, including drug use, high-risk sexual behaviors, and gender-based disparities. Although PrEP is a proven HIV prevention method, uptake among this population remains low due to stigma, limited healthcare access, and co-occurring mental health conditions. To address these barriers, this pilot trial will implement and evaluate MI-PrEP, a brief intervention designed to enhance motivation for PrEP use, and CETA + MI-PrEP, a more intensive mental health intervention that combines MI-PrEP with a modular, trans-diagnostic therapy addressing depression, anxiety, trauma, and substance use.
The MI-PrEP intervention will consist of two one-hour counseling sessions providing PrEP education, motivation enhancement, and problem-solving strategies. Participants in the CETA + MI-PrEP arm will receive the same MI-PrEP sessions in addition to up to 14 weekly CETA sessions tailored to individual mental health and substance use needs. The TAU control group will receive PrEP education, mental health and substance use resources, and optional referrals to PrEP and harm reduction services. The primary outcomes of the study will be feasibility, PrEP uptake, and adherence at one and six months post-intervention. Secondary outcomes include changes in depression, anxiety, PTSD symptoms, substance use behaviors, and HIV risk behaviors.
Participants will complete baseline, one-month, and six-month follow-up assessments. Quantitative data will be collected through structured surveys, while qualitative data will be obtained from in-depth interviews with a subset of trial participants and intervention counselors. Thematic analysis will be used to assess intervention feasibility, fidelity, and perceived impact. Statistical analyses, including logistic regression and mixed-effects models, will evaluate intervention effects on PrEP uptake, adherence, and mental health outcomes.
Safety protocols will be implemented to assess and manage risks related to suicide, homicide, interpersonal violence, and overdose. Ethical approvals have been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, the Muhimbili University of Health and Allied Sciences Ethics Review Committee, and the National Institute for Medical Research in Tanzania. The study also involves a Community Advisory Board (CAB) composed of WWUD and a Study Advisory Board (SAB) including representatives from academia, civil society, government agencies as well as healthcare providers and WWUD to ensure ethical and community-informed implementation.
Findings from this pilot trial will inform scalable strategies to support PrEP uptake among WWUD and other key populations at high risk for HIV infection. The results will be disseminated through community meetings, scientific conferences, and peer-reviewed publications, contributing to improved HIV prevention programming for WWUD in Tanzania and beyond.
- Conditions
- HIV, Mental Health, Substance Use (Drugs, Alcohol)
- Being tested
- Motivational Interviewing for PreP, Common Elements Treatment Approach (CETA) + MI-PrEP
- Keywords
- HIV pre-exposure prophylaxis (PrEP), Mental health, substance use
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing for PrePBehavioural
Participants will receive MI-PrEP only will receive two 1-hour sessions with an intervention counselor. The first session will include information on PrEP and other HIV prevention and harm reduction strategies, and discussion on PrEP contemplation, importance, and confidence, and problem-solving around identified barriers to PrEP. The session will also include information on other available harm reduction strategies and services, including medications for opioid use disorder. The second session will focus on following up on any PrEP actions taken, challenges encountered, and problem-solving to address any challenges. Those ready to be linked to PrEP and/or harm reduction services will be offered an escort to a designated PrEP and/or opioid treatment clinic site or other harm reduction services.
Common Elements Treatment Approach (CETA) + MI-PrEPBehavioural
Participants will receive CETA+MI-PrEP will receive 7 to 14 weekly one-hour sessions from an intervention counselor. Similar to the MI-PrEP group, women in this study arm will receive the two 1-hour MI-PrEP sessions with an intervention counselor with linkages to PrEP and/or harm reduction services. Women will then begin CETA sessions. The CETA intervention component is a modular and flexible approach comprised of nine elements that can be combined in various ways, including different sequences, to address clients' presenting symptoms and problem areas. CETA currently includes key engagement strategies, including MI, throughout the intervention. The intervention counselor will determine the specific intervention component sessions, sequence of sessions, and dose, or frequency of sessions, based on the primary problem area identified by the participant and intervention counselor as reported in the baseline assessment survey and initial discussions.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing for PreP (MI-PrEP) | Experimental | Participants randomized to this arm will receive MI-PrEP only will receive two 1-hour sessions with an intervention counselor. The first session will include information on PrEP and other HIV prevention and harm reduction strategies, and discussion on PrEP contemplation, importance, and confidence, and problem-solving around identified barriers to PrEP. The session will also include information on other available harm reduction strategies and services, including medications for opioid use disorder. The second session will focus on following up on any PrEP actions taken, challenges encountered, and problem-solving to address any challenges. Those ready to be linked to PrEP and/or harm reduction services will be offered an escort to a designated PrEP and/or opioid treatment clinic site or other harm reduction services. Receives: Behavioral: Motivational Interviewing for PreP |
| Common Elements Treatment Approach (CETA) + MI-PrEP | Experimental | Participants randomized to this arm will receive CETA+MI-PrEP will receive 7 to 14 weekly one-hour sessions from an intervention counselor. Similar to the MI-PrEP group, women in this study arm will receive the two 1-hour MI-PrEP sessions with an intervention counselor with linkages to PrEP and/or harm reduction services. Women will then begin CETA sessions. The CETA intervention component is a modular and flexible approach comprised of nine elements that can be combined in various ways, including different sequences, to address clients' presenting symptoms and problem areas. CETA currently includes key engagement strategies, including MI, throughout the intervention. The intervention counselor will determine the specific intervention component sessions, sequence of sessions, and dose, or frequency of sessions, based on the primary problem area identified by the participant and intervention counselor as reported in the baseline assessment survey and initial discussions. Receives: Behavioral: Common Elements Treatment Approach (CETA) + MI-PrEP |
| Treatment as Usual (TAU) | No intervention | Participants randomized to this arm will receive the treatment as usual. Participants will be offered information on PrEP, including its benefits and potential side effects, and PrEP, substance use disorder treatment, including medications for opioid use disorder, overdose prevention and management, and mental health services available, as well as optional escorted linkage to a designated PrEP and/or opioid treatment clinic site. Participants will be offered linkages to a designated PrEP and/or opioid treatment clinic site or other harm reduction services, in line with current community outreach practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible participants who enroll
Proportion of eligible participants who enroll (Recruitment feasibility)
Measured: At baseline
Proportion of target sample size enrolled
Proportion of target sample size enrolled in the study - Actual number of women enrolled/Planned number of women to enroll (Recruitment feasibility)
Measured: At baseline
Mean proportion of planned sessions attended
Mean attendance rate, i.e., proportion of planned sessions attended (Demand \& engagement)
Measured: 6 months post-enrollment
Proportion completing all planned sessions
Proportion completing all planned sessions (Intervention delivery feasibility)
Measured: 6-months post-enrollment
Proportion completing follow-up survey assessment
Proportion completing 6-month follow-up survey assessment (Retention feasibility)
Measured: 6 months post-enrollment
Proportion satisfied with the intervention
Proportion satisfied or very satisfied with the intervention
Measured: 6 months post-enrollment
Proportion of participants who report PrEP initiation
Self-reported survey measures: 1) Have you been prescribed PrEP medications? and 2) Have you received PrEP medications within 3 months of HIV testing?
Measured: 6 months post-enrollment
Secondary outcomes (5)
Change from baseline in depressive symptoms at 6 months as assessed by the PHQ-9
Change from baseline in depressive symptoms at 6 months post-enrolled as assessed by the Patient Health Questionnaire-9 (PHQ-9); Scoring: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)
Measured: Baseline and 6 months post-enrollment
Change from baseline in general anxiety symptoms at 6 months as assessed by GAD-7
Change from baseline in general anxiety symptoms at 6 months post-enrollment as assessed by the Generalized Anxiety Disorder-7 (GAD-7); 7-item scale (GAD-7) range from 0 to 21, higher scores reflect greater symptom severity.
Measured: Baseline and 6 months post-enrollment
Change from baseline in PTSD symptoms at 6 months as assessed by HTQ
Change from baseline in post-traumatic stress disorder (PTSD) symptoms at 6 months as assessed by the Harvard Trauma Questionnaire (HTQ); Score range 16-64. Higher scores indicate higher levels of PTSD symptoms
Measured: Baseline and 6 months post-enrollment
Change from baseline in substance use risk score at 6 months as assessed by ASSIST Global Continuum of Illicit Drug Risk Score
Change from baseline in substance use risk score at 6 months as assessed by the Alcohol, Smoking, and Substance Involvement Screening (ASSIST) Global Continuum of Illicit Drug Risk Score. Score ranges from 0 to 308, with higher scores indicating greater risk
Measured: Baseline and 6 months post-enrollment
Change from baseline in gender-based violence score at 6 months as assessed by VAWI
Change from baseline in gender-based violence score at 6 months as assessed by the World Health Organization (WHO) Violence Against Women Instrument (VAWI). 13 Yes/No questions. Higher score reflect higher gender based violence.
Measured: Baseline and 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start25 Jul 2025
- Primary completion9 Oct 2026
- Study completion9 Oct 2026
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 HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Haneefa T Saleem, PhD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835751
- Sponsor's protocol ID
- IRB00025580
- Other IDs
- R34DA058566
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant-level data that will be shared includes de-identified interview, survey, and symptom monitoring data. These data will be stored in the National Addiction \& HIV Data Archive Program (NAHDAP) digital data repository of the Inter-university Consortium for Political and Social Research (ICPSR). Public use data will be accessible to registered users who agree to the ICPSR Terms of Use, while restricted access data, which may contain potentially identifying information, will be available through a virtual data enclave system for approved researchers under a restricted data contract. The rationale for sharing these data is to enable researchers to perform additional analyses to address important scientific questions related to PrEP engagement among women who use drugs, inform HIV prevention strategies, and contribute to the development of culturally appropriate interventions.
Publications
Saleem H, Atkins K, Skavenski S, Nonyane BA, Chitamwebwa F, Mtaita S, Mwansa D, Luswetula A, Murray LK, Likindikoki S. Integrating the Common Elements Treatment Approach and motivational interviewing to improve HIV pre-exposure prophylaxis engagement among women who use drugs in Tanzania: protocol for a pilot randomised controlled trial. BMJ Open. 2026 Jan 8;16(1):e114522. doi: 10.1136/bmjopen-2025-114522.
PubMed 41506761
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing PrEP Among Women Who Use Drugs in Tanzania
- ClinicalTrials.gov ID
- NCT06835751
- Acronym / sponsor ID
- IRB00025580
- Conditions
- HIV, Mental Health, Substance Use (Drugs, Alcohol)
- Keywords
- HIV pre-exposure prophylaxis (PrEP), Mental health, substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences, National Institute on Drug Abuse (NIDA)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 19 Feb 2025 (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.
This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support.
The study will enroll 200 women who use drugs in Dar es Salaam, Tanzania. These women will be randomly assigned to one of three groups:
Motivational Interviewing for PrEP (MI-PrEP) Only - Women in this group will receive two one-hour counseling sessions focused on HIV prevention, PrEP education, and problem-solving to help the women start and continue using PrEP.
Common Elements Treatment Approach (CETA) + MI-PrEP - Women in this group will receive the same MI-PrEP counseling sessions plus additional mental health counseling (up to 14 sessions) tailored to the women's individual needs, addressing issues like depression, anxiety, trauma, and substance use.
Treatment as Usual (TAU) - Women in this group will receive basic information on PrEP, mental health, and harm reduction, along with optional referrals to PrEP or drug treatment clinics.
The study will evaluate feasibility of administering MI-PrEP and CETA+MI-PrEP and how well these interventions help women start and stay on PrEP, as well as the intervention's impact on mental health and drug use. Researchers will also interview participants and counselors to understand the participants and counselors experiences with the program.
The goal is to find effective ways to support PrEP use among women who use drugs and to develop a model that could be used in similar settings to reduce HIV risk. This pilot study is approved by ethics committees in the United States and Tanzania, and results will be shared with communities, policymakers, and researchers.
Detailed description
This study is a pilot clinical trial aiming to assess the feasibility and preliminary efficacy of two interventions designed to improve PrEP engagement among women who use drugs (WWUD) in Dar es Salaam, Tanzania. The trial will enroll 200 participants who will be randomly assigned to one of three study arms: Motivational Interviewing for PrEP (MI-PrEP) only, Common Elements Treatment Approach (CETA) + MI-PrEP, or Enhanced Treatment as Usual (TAU). The study will evaluate whether these interventions can enhance PrEP uptake and adherence, while also addressing mental health and substance use challenges common among WWUD.
WWUD in Tanzania are at a heightened risk of acquiring HIV due to intersecting vulnerabilities, including drug use, high-risk sexual behaviors, and gender-based disparities. Although PrEP is a proven HIV prevention method, uptake among this population remains low due to stigma, limited healthcare access, and co-occurring mental health conditions. To address these barriers, this pilot trial will implement and evaluate MI-PrEP, a brief intervention designed to enhance motivation for PrEP use, and CETA + MI-PrEP, a more intensive mental health intervention that combines MI-PrEP with a modular, trans-diagnostic therapy addressing depression, anxiety, trauma, and substance use.
The MI-PrEP intervention will consist of two one-hour counseling sessions providing PrEP education, motivation enhancement, and problem-solving strategies. Participants in the CETA + MI-PrEP arm will receive the same MI-PrEP sessions in addition to up to 14 weekly CETA sessions tailored to individual mental health and substance use needs. The TAU control group will receive PrEP education, mental health and substance use resources, and optional referrals to PrEP and harm reduction services. The primary outcomes of the study will be feasibility, PrEP uptake, and adherence at one and six months post-intervention. Secondary outcomes include changes in depression, anxiety, PTSD symptoms, substance use behaviors, and HIV risk behaviors.
Participants will complete baseline, one-month, and six-month follow-up assessments. Quantitative data will be collected through structured surveys, while qualitative data will be obtained from in-depth interviews with a subset of trial participants and intervention counselors. Thematic analysis will be used to assess intervention feasibility, fidelity, and perceived impact. Statistical analyses, including logistic regression and mixed-effects models, will evaluate intervention effects on PrEP uptake, adherence, and mental health outcomes.
Safety protocols will be implemented to assess and manage risks related to suicide, homicide, interpersonal violence, and overdose. Ethical approvals have been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, the Muhimbili University of Health and Allied Sciences Ethics Review Committee, and the National Institute for Medical Research in Tanzania. The study also involves a Community Advisory Board (CAB) composed of WWUD and a Study Advisory Board (SAB) including representatives from academia, civil society, government agencies as well as healthcare providers and WWUD to ensure ethical and community-informed implementation.
Findings from this pilot trial will inform scalable strategies to support PrEP uptake among WWUD and other key populations at high risk for HIV infection. The results will be disseminated through community meetings, scientific conferences, and peer-reviewed publications, contributing to improved HIV prevention programming for WWUD in Tanzania and beyond.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing for PreP (MI-PrEP) | Experimental | Behavioral: Motivational Interviewing for PrePParticipants randomized to this arm will receive MI-PrEP only will receive two 1-hour sessions with an intervention counselor. The first session will include information on PrEP and other HIV prevention and harm reduction strategies, and discussion on PrEP contemplation, importance, and confidence, and problem-solving around identified barriers to PrEP. The session will also include information on other available harm reduction strategies and services, including medications for opioid use disorder. The second session will focus on following up on any PrEP actions taken, challenges encountered, and problem-solving to address any challenges. Those ready to be linked to PrEP and/or harm reduction services will be offered an escort to a designated PrEP and/or opioid treatment clinic site or other harm reduction services. |
| Common Elements Treatment Approach (CETA) + MI-PrEP | Experimental | Behavioral: Common Elements Treatment Approach (CETA) + MI-PrEPParticipants randomized to this arm will receive CETA+MI-PrEP will receive 7 to 14 weekly one-hour sessions from an intervention counselor. Similar to the MI-PrEP group, women in this study arm will receive the two 1-hour MI-PrEP sessions with an intervention counselor with linkages to PrEP and/or harm reduction services. Women will then begin CETA sessions. The CETA intervention component is a modular and flexible approach comprised of nine elements that can be combined in various ways, including different sequences, to address clients' presenting symptoms and problem areas. CETA currently includes key engagement strategies, including MI, throughout the intervention. The intervention counselor will determine the specific intervention component sessions, sequence of sessions, and dose, or frequency of sessions, based on the primary problem area identified by the participant and intervention counselor as reported in the baseline assessment survey and initial discussions. |
| Treatment as Usual (TAU) | No intervention | –Participants randomized to this arm will receive the treatment as usual. Participants will be offered information on PrEP, including its benefits and potential side effects, and PrEP, substance use disorder treatment, including medications for opioid use disorder, overdose prevention and management, and mental health services available, as well as optional escorted linkage to a designated PrEP and/or opioid treatment clinic site. Participants will be offered linkages to a designated PrEP and/or opioid treatment clinic site or other harm reduction services, in line with current community outreach practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female sex
- 18 years or older
- Non-reactive or negative HIV test result
- Self-reported drug- or sex-related HIV risk behaviors in the past six months
- Hazardous or harmful opioid use in the past six months
Key exclusion criteria (4 listed)
- Reactive or positive HIV test result
- Currently taking PrEP
- Actively suicidal, homicidal, or psychotic, and needing immediate hospitalization based on safety assessments
- Unable to provide informed consent
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 |
|---|---|---|
| Motivational Interviewing for PrePParticipants will receive MI-PrEP only will receive two 1-hour sessions with an intervention counselor. The first session will include information on PrEP and other HIV prevention and harm reduction strategies, and discussion on PrEP contemplation, importance, and confidence, and problem-solving around identified barriers to PrEP. The session will also include information on other available harm reduction strategies and services, including medications for opioid use disorder. The second session will focus on following up on any PrEP actions taken, challenges encountered, and problem-solving to address any challenges. Those ready to be linked to PrEP and/or harm reduction services will be offered an escort to a designated PrEP and/or opioid treatment clinic site or other harm reduction services. | Behavioural | Motivational Interviewing for PreP (MI-PrEP) |
| Common Elements Treatment Approach (CETA) + MI-PrEPParticipants will receive CETA+MI-PrEP will receive 7 to 14 weekly one-hour sessions from an intervention counselor. Similar to the MI-PrEP group, women in this study arm will receive the two 1-hour MI-PrEP sessions with an intervention counselor with linkages to PrEP and/or harm reduction services. Women will then begin CETA sessions. The CETA intervention component is a modular and flexible approach comprised of nine elements that can be combined in various ways, including different sequences, to address clients' presenting symptoms and problem areas. CETA currently includes key engagement strategies, including MI, throughout the intervention. The intervention counselor will determine the specific intervention component sessions, sequence of sessions, and dose, or frequency of sessions, based on the primary problem area identified by the participant and intervention counselor as reported in the baseline assessment survey and initial discussions. | Behavioural | Common Elements Treatment Approach (CETA) + MI-PrEP |
Primary outcome
Proportion of eligible participants who enroll
Time frame: At baseline
Proportion of eligible participants who enroll (Recruitment feasibility)
Proportion of target sample size enrolled
Time frame: At baseline
Proportion of target sample size enrolled in the study - Actual number of women enrolled/Planned number of women to enroll (Recruitment feasibility)
Mean proportion of planned sessions attended
Time frame: 6 months post-enrollment
Mean attendance rate, i.e., proportion of planned sessions attended (Demand \& engagement)
Proportion completing all planned sessions
Time frame: 6-months post-enrollment
Proportion completing all planned sessions (Intervention delivery feasibility)
Proportion completing follow-up survey assessment
Time frame: 6 months post-enrollment
Proportion completing 6-month follow-up survey assessment (Retention feasibility)
Proportion satisfied with the intervention
Time frame: 6 months post-enrollment
Proportion satisfied or very satisfied with the intervention
Proportion of participants who report PrEP initiation
Time frame: 6 months post-enrollment
Self-reported survey measures: 1) Have you been prescribed PrEP medications? and 2) Have you received PrEP medications within 3 months of HIV testing?
5 secondary outcomes
Change from baseline in depressive symptoms at 6 months as assessed by the PHQ-9
Time frame: Baseline and 6 months post-enrollment
Change from baseline in general anxiety symptoms at 6 months as assessed by GAD-7
Time frame: Baseline and 6 months post-enrollment
Change from baseline in PTSD symptoms at 6 months as assessed by HTQ
Time frame: Baseline and 6 months post-enrollment
Change from baseline in substance use risk score at 6 months as assessed by ASSIST Global Continuum of Illicit Drug Risk Score
Time frame: Baseline and 6 months post-enrollment
Change from baseline in gender-based violence score at 6 months as assessed by VAWI
Time frame: Baseline and 6 months post-enrollment
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 16 Oct 2026.
- Derived from this study: PubMed 41506761Saleem H, Atkins K, Skavenski S, Nonyane BA, Chitamwebwa F, Mtaita S, Mwansa D, Luswetula A, Murray LK, Likindikoki S. Integrating the Common Elements Treatment Approach and motivational interviewing to improve HIV pre-exposure prophylaxis engagement among women who use drugs in Tanzania: protocol for a pilot randomised controlled trial. BMJ Open. 2026 Jan 8;16(1):e114522. doi: 10.1136/bmjopen-2025-114522.
- Individual participant dataSharing planned: Yes. The individual participant-level data that will be shared includes de-identified interview, survey, and symptom monitoring data. These data will be stored in the National Addiction \& HIV Data Archive Program (NAHDAP) digital data repository of the Inter-university Consortium for Political and Social Research (ICPSR). Public use data will be accessible to registered users who agree to the ICPSR Terms of Use, while restricted access data, which may contain potentially identifying information, will be available through a virtual data enclave system for approved researchers under a restricted data contract. The rationale for sharing these data is to enable researchers to perform additional analyses to address important scientific questions related to PrEP engagement among women who use drugs, inform HIV prevention strategies, and contribute to the development of culturally appropriate interventions.
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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.
Haneefa T Saleem, PhD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing for PreP and Common Elements Treatment Approach (CETA) + MI-PrEP in people with HIV and Mental Health, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Tanzania.
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 6 inclusion and 4 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 16 Oct 2026. 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 Tanzania. 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?
Proportion of eligible participants who enroll (time frame: At baseline). The study lists 7 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 NCT06835751, 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 16 Oct 2026.