HIVNCT02733003
Implementation Research for Vulnerable Women in South Africa
A study testing Women's Health CoOp (WHC) in people with HIV and Substance Abuse, run by RTI International at 2 sites in 2 countries.
Trial summary
This study sought to implement the Women's Health CoOp (Cooperative) (WHC) intervention into healthcare, antenatal, and substance treatment clinics in South Africa and translated this evidence-based intervention into real-world settings. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Abuse
- What is being tested?
- Women's Health CoOp (WHC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to 4 Dec 2018
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Clinic Inclusion Criteria:
- HIV/antenatal clinic or substance abuse treatment clinic
- Located in townships surrounding Cape Town
- Willing to take part in study
Patient Inclusion Criteria:
- Female;
- 18 to 45 years of age;
- Reports use of at least one drug, including alcohol, at least weekly during the previous 3 months;
- Reports unprotected sex with a male partner in the past 6 months;
- Has a positive HIV test result from either the participating health clinic or rehab clinic, or a clinic issued ARV card or ARV medication as proof of positive status;
- Reports the intention to remain in the area for at least the next 6 months;
- Provides informed consent to participate.
Patient Exclusion Criteria:
- Not HIV Positive
- Not willing to do alcohol and drug screening
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
RTI International
Research Triangle Park, North Carolina, 27709
About this study
This study sought to implement the Women's Health CoOp (Cooperative) (WHC) intervention into healthcare, antenatal, and substance treatment clinics in South Africa and translated this evidence-based intervention into real-world settings. Implementation, service, and patient outcomes will be evaluated through an iterative stepped wedge design.
Read the detailed description
This five-year implementation science study used a cluster-randomized stepped-wedge design to evaluate the implementation, service, and patient outcomes associated with the WHC for alcohol and other drug (AOD)-using HIV positive women in usual care settings.
A list of four substance use treatment clinics and four healthcare clinics, identified and approved by the City of Cape Town, South Africa were randomized to begin the intervention during one of the four cycles. Each healthcare clinic was paired with a substance use treatment clinic based on geographic proximity, and each pair was randomized by computer into four succeeding 6-month implementation cycles where implementation of the WHC took place simultaneously at the paired sites. Approximately 120 HIV positive participants were recruited in each cycle (approximately 60 from each clinic) for the patient level outcomes.
Both qualitative and quantitative data were collected to assess the appropriateness of marketing plans developed through formative methods, as well as the acceptability, adoption, feasibility, fidelity, and sustainability of the WHC intervention implementation as well as service outcomes (comprehensive services and timely service linkages) during each implementation cycle.
Each implementation cycle included a pre-implementation period, implementation period (6-months), and post-implementation period. In the pre-implementation period, focus groups and questionnaires surveys were conducted with clinic staff to assess the readiness of each site to implement the WHC. During the implementation period, employees at each site were trained to facilitate the WHC and the WHC was integrated into site operations. Subsequently, in the post-implementation period the researchers collected data related to challenges, benefits, and sustainability from each site. The process was repeated for each cycle and these formative periods between cycles were used to inform backward- and forward- implementation strategies, make modifications to the WHC, and leave time for site-specific training for the next cycle. Consequently, the sites randomized to the first cycle had the longest post-intervention observation period whose implementation sustainability was checked through fidelity forms and sustainability questionnaires, and sites in the fourth cycle benefited the most because of lessons learned and information shared from previous cycles.
The intervention was implemented in a group, however there were instances when only one participant was available and therefore the intervention was implemented one-on-one. The WHC has previously been tested in group and one-on-one formats and both have demonstrated consistent significant intervention effects. Research staff trained clinic staff members to deliver the intervention. The intervention was delivered by clinic staff and was not part of the research. The research questions were related to the feasibility of implementing the intervention in clinics and its acceptability to clinic staff and patients. The researchers collected information on patient-level outcomes to determine if the intervention was effective when it was delivered by clinic staff to patients in the clinic. Also, to assess acceptability of the intervention workshops among patients, the researchers conducted post-implementation focus groups with a randomly selected sub-sample of participants who participated in the intervention and completed their final 6-month appointment in each implementation cycle.
Implementation of the WHC in usual care settings has the potential to reach more vulnerable women and could have a high public health impact if implementation is shown to be effective and sustainable in these real-world settings.
- Conditions
- HIV, Substance Abuse
- Being tested
- Women's Health CoOp (WHC)
- Keywords
- Implementation Science, HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization, Linkage to care, Gender-based Violence, Antiretroviral Therapy (ART)
- Medical subject headings
- Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women's Health CoOp (WHC)Behavioural
Participants in this group will participate in two workshops of the woman-focused intervention about HIV/STIs, sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues.
| Study group | Role | What they receive |
|---|---|---|
| Women's Health CoOp (WHC) | Experimental | This is an adapted behavioral intervention for women in South Africa, who use alcohol and other drugs and are living with HIV or at risk of acquiring HIV. Receives: Behavioral: Women's Health CoOp (WHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients
Measured: Baseline
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients
Measured: 6-months post-enrollment
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
Explore perceived appropriateness of implementing the intervention through clinic staff survey
Measured: Baseline
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Assess perceived acceptability through qualitative focus groups with clinic staff and patients
Measured: Baseline
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Assess perceived acceptability through qualitative focus groups with clinic staff and patients
Measured: 6-months post-enrollment
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Assess perceived acceptability through patient interviews
Measured: Baseline
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Assess perceived acceptability through patient interviews
Measured: 6-months post-enrollment
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Assess perceived acceptability through clinic staff survey
Measured: Baseline
Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention
Assess adoption of the intervention through qualitative focus groups with clinic staff.
Measured: Baseline
Implementation and Service Outcome: Adoption of the WHC intervention
Assess adoption of the intervention through qualitative focus groups with clinic staff.
Measured: 6-months post-enrollment
Implementation and Service Outcome: Cost
Assess start up and ongoing implementation costs
Measured: Baseline
Implementation and Service Outcome: Cost
Assess start up and ongoing implementation costs
Measured: 6-months post-enrollment
Implementation and Service Outcome: Feasibility
Exposure as measured by the ratio of the number of intervention workshops delivered to participants (a total of two across the intervention window) (compared to the total expected intervention visits. Acceptable retention measured at ≥85% of patients who complete both workshops within the intervention window.
Measured: Throughout the period of the study, up to a maximum of one year
Implementation and Service Outcome: Fidelity
Observation: fidelity item scores where a 90% or above fidelity rating will indicate acceptable fidelity
Measured: Throughout the study at bimonthly intervals for up to one year
Implementation and Service Outcomes: Sustainability
Examine sustainability through qualitative focus groups with clinic staff
Measured: Throughout the period of the study, up to a maximum of one year
Implementation and Service Outcomes: Sustainability
Examine sustainability with clinic staff using an adapted TCU Workshop Assessment Follow-up Scale
Measured: 6 months post-intervention
Secondary outcomes (20)
Antiretroviral Therapy (ART) Initiation and Adherence
Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and were adhering to ART.
Measured: Baseline
Antiretroviral Therapy (ART) Initiation and Adherence
Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and were adhering to ART.
Measured: 6 months post-enrollment
Alcohol Use - self-reported frequency and amount
Participants' self-reported frequency and amount of alcohol use will be used to assess recent alcohol use.
Measured: Baseline
Alcohol Use - self-reported frequency and amount
Participants' self-reported frequency and amount of alcohol use will be used to assess recent alcohol use.
Measured: 6 months post-enrollment
Alcohol Use
Breathalyzer test results will be used to assess recent alcohol use.
Measured: Baseline
Alcohol Use
Breathalyzer test results will be used to assess recent alcohol use.
Measured: 6 months post-enrollment
Substance Use
Participants' frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use will be used to assess recent substance use.
Measured: Baseline
Substance Use
Participants' frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use will be used to assess recent substance use.
Measured: 6-months post-enrollment
Substance use
Urine drug screen test results will be used to assess recent use of drugs (benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax).
Measured: Baseline
Substance use
Urine drug screen test results will be used to assess recent use of drugs (benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax).
Measured: 6-months post-enrollment
Sexual Risk
Participants' self-reported frequency of condom use.
Measured: Baseline
Sexual Risk
Participants' self-reported frequency of condom use.
Measured: 6-months post-enrollment
Sexual Risk
Participants' self-reported number of sex partners.
Measured: Baseline
Sexual Risk
Participants' self-reported number of sex partners.
Measured: 6-months post-enrollment
Violence/Victimization
Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex.
Measured: Baseline
Violence/Victimization
Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex.
Measured: 6-months post-enrollment
Sexual Communication
The extent to which women have the skills to discuss sexual topics with their partners
Measured: Baseline
Sexual Communication
The extent to which women have the skills to discuss sexual topics with their partners
Measured: 6-months post-enrollment
Relationship Power
The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS)
Measured: Baseline
Relationship Power
The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS)
Measured: 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 posted11 Apr 2016 (estimated)
- Study startSep 2015
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Kheth'Impilo
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733003
- Sponsor's protocol ID
- R01AA022882
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2016
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wechsberg WM, Ndirangu JW, Speizer IS, Zule WA, Gumula W, Peasant C, Browne FA, Dunlap L. An implementation science protocol of the Women's Health CoOp in healthcare settings in Cape Town, South Africa: A stepped-wedge design. BMC Womens Health. 2017 Sep 18;17(1):85. doi: 10.1186/s12905-017-0433-8.
PubMed 28923034Howard BN, Van Dorn R, Myers BJ, Zule WA, Browne FA, Carney T, Wechsberg WM. Barriers and facilitators to implementing an evidence-based woman-focused intervention in South African health services. BMC Health Serv Res. 2017 Nov 21;17(1):746. doi: 10.1186/s12913-017-2669-2.
PubMed 29157230Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Kline TL, Gichane M, Zule WA. Outcomes of Implementing in the Real World the Women's Health CoOp Intervention in Cape Town, South Africa. AIDS Behav. 2021 Dec;25(Suppl 3):276-289. doi: 10.1007/s10461-021-03251-7. Epub 2021 Apr 23.
PubMed 33891233Gichane MW, Wechsberg WM, Ndirangu J, Browne FA, Bonner CP, Grimwood A, Shaikh N, Howard B, Zule WA. Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa. Drug Alcohol Depend. 2020 Oct 1;215:108206. doi: 10.1016/j.drugalcdep.2020.108206. Epub 2020 Aug 1.
PubMed 32771909Browne FA, Gichane MW, Shangase N, Ndirangu J, Bonner CP, Wechsberg WM. Social Determinants of Alcohol and Other Drug Misuse Among Women Living with HIV in Economically Underserved Communities in Cape Town, South Africa: A Cross-Sectional Study. AIDS Behav. 2023 Apr;27(4):1329-1338. doi: 10.1007/s10461-022-03869-1. Epub 2022 Nov 7.
PubMed 36344731Gichane MW, Wechsberg WM, Ndirangu J, Howard B, Bonner CP, Browne FA, Zule WA. Sustainability of a gender-focused HIV and alcohol risk-reduction intervention in usual care settings in South Africa: a mixed methods analysis. AIDS Care. 2021 Jan-Dec;33(sup1):11-17. doi: 10.1080/09540121.2021.1966694. Epub 2021 Sep 19.
PubMed 34538158Ndirangu JW, Gichane MW, Browne FA, Bonner CP, Zule WA, Cox EN, Smith KM, Carney T, Wechsberg WM. 'We have goals but [it is difficult]'. Barriers to antiretroviral therapy adherence among women using alcohol and other drugs living with HIV in South Africa. Health Expect. 2022 Apr;25(2):754-763. doi: 10.1111/hex.13422. Epub 2022 Jan 21.
PubMed 35060260Washio Y, Browne FA, Ndirangu J, Kline TL, Wechsberg WM. Antiretroviral Therapy (ART) Adherence and Prenatal Alcohol Use among Women Who Are Pregnant with HIV in South Africa. Int J Environ Res Public Health. 2021 Jul 13;18(14):7446. doi: 10.3390/ijerph18147446.
PubMed 34299897Wechsberg WM, Browne FA, Bonner CP, Washio Y, Howard BN, van der Drift I. Current Interventions for People Living with HIV Who Use Alcohol: Why Gender Matters. Curr HIV/AIDS Rep. 2021 Aug;18(4):351-364. doi: 10.1007/s11904-021-00558-x. Epub 2021 Jun 10.
PubMed 34110591
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
- Implementation Research for Vulnerable Women in South Africa
- ClinicalTrials.gov ID
- NCT02733003
- Acronym / sponsor ID
- R01AA022882
- Conditions
- HIV, Substance Abuse
- Keywords
- Implementation Science, HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization, Linkage to care, Gender-based Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Kheth'Impilo
- Study start
- Sep 2015 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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 sought to implement the Women's Health CoOp (Cooperative) (WHC) intervention into healthcare, antenatal, and substance treatment clinics in South Africa and translated this evidence-based intervention into real-world settings. Implementation, service, and patient outcomes will be evaluated through an iterative stepped wedge design.
Detailed description
This five-year implementation science study used a cluster-randomized stepped-wedge design to evaluate the implementation, service, and patient outcomes associated with the WHC for alcohol and other drug (AOD)-using HIV positive women in usual care settings.
A list of four substance use treatment clinics and four healthcare clinics, identified and approved by the City of Cape Town, South Africa were randomized to begin the intervention during one of the four cycles. Each healthcare clinic was paired with a substance use treatment clinic based on geographic proximity, and each pair was randomized by computer into four succeeding 6-month implementation cycles where implementation of the WHC took place simultaneously at the paired sites. Approximately 120 HIV positive participants were recruited in each cycle (approximately 60 from each clinic) for the patient level outcomes.
Both qualitative and quantitative data were collected to assess the appropriateness of marketing plans developed through formative methods, as well as the acceptability, adoption, feasibility, fidelity, and sustainability of the WHC intervention implementation as well as service outcomes (comprehensive services and timely service linkages) during each implementation cycle.
Each implementation cycle included a pre-implementation period, implementation period (6-months), and post-implementation period. In the pre-implementation period, focus groups and questionnaires surveys were conducted with clinic staff to assess the readiness of each site to implement the WHC. During the implementation period, employees at each site were trained to facilitate the WHC and the WHC was integrated into site operations. Subsequently, in the post-implementation period the researchers collected data related to challenges, benefits, and sustainability from each site. The process was repeated for each cycle and these formative periods between cycles were used to inform backward- and forward- implementation strategies, make modifications to the WHC, and leave time for site-specific training for the next cycle. Consequently, the sites randomized to the first cycle had the longest post-intervention observation period whose implementation sustainability was checked through fidelity forms and sustainability questionnaires, and sites in the fourth cycle benefited the most because of lessons learned and information shared from previous cycles.
The intervention was implemented in a group, however there were instances when only one participant was available and therefore the intervention was implemented one-on-one. The WHC has previously been tested in group and one-on-one formats and both have demonstrated consistent significant intervention effects. Research staff trained clinic staff members to deliver the intervention. The intervention was delivered by clinic staff and was not part of the research. The research questions were related to the feasibility of implementing the intervention in clinics and its acceptability to clinic staff and patients. The researchers collected information on patient-level outcomes to determine if the intervention was effective when it was delivered by clinic staff to patients in the clinic. Also, to assess acceptability of the intervention workshops among patients, the researchers conducted post-implementation focus groups with a randomly selected sub-sample of participants who participated in the intervention and completed their final 6-month appointment in each implementation cycle.
Implementation of the WHC in usual care settings has the potential to reach more vulnerable women and could have a high public health impact if implementation is shown to be effective and sustainable in these real-world settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women's Health CoOp (WHC) | Experimental | Behavioral: Women's Health CoOp (WHC)This is an adapted behavioral intervention for women in South Africa, who use alcohol and other drugs and are living with HIV or at risk of acquiring HIV. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Women's Health CoOp (WHC)Participants in this group will participate in two workshops of the woman-focused intervention about HIV/STIs, sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. | Behavioural | Women's Health CoOp (WHC) |
Primary outcome
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
Time frame: Baseline
Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
Time frame: 6-months post-enrollment
Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
Time frame: Baseline
Explore perceived appropriateness of implementing the intervention through clinic staff survey
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Time frame: Baseline
Assess perceived acceptability through qualitative focus groups with clinic staff and patients
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Time frame: 6-months post-enrollment
Assess perceived acceptability through qualitative focus groups with clinic staff and patients
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Time frame: Baseline
Assess perceived acceptability through patient interviews
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Time frame: 6-months post-enrollment
Assess perceived acceptability through patient interviews
Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
Time frame: Baseline
Assess perceived acceptability through clinic staff survey
Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention
Time frame: Baseline
Assess adoption of the intervention through qualitative focus groups with clinic staff.
Implementation and Service Outcome: Adoption of the WHC intervention
Time frame: 6-months post-enrollment
Assess adoption of the intervention through qualitative focus groups with clinic staff.
Implementation and Service Outcome: Cost
Time frame: Baseline
Assess start up and ongoing implementation costs
Implementation and Service Outcome: Cost
Time frame: 6-months post-enrollment
Assess start up and ongoing implementation costs
Implementation and Service Outcome: Feasibility
Time frame: Throughout the period of the study, up to a maximum of one year
Exposure as measured by the ratio of the number of intervention workshops delivered to participants (a total of two across the intervention window) (compared to the total expected intervention visits. Acceptable retention measured at ≥85% of patients who complete both workshops within the intervention window.
Implementation and Service Outcome: Fidelity
Time frame: Throughout the study at bimonthly intervals for up to one year
Observation: fidelity item scores where a 90% or above fidelity rating will indicate acceptable fidelity
Implementation and Service Outcomes: Sustainability
Time frame: Throughout the period of the study, up to a maximum of one year
Examine sustainability through qualitative focus groups with clinic staff
Implementation and Service Outcomes: Sustainability
Time frame: 6 months post-intervention
Examine sustainability with clinic staff using an adapted TCU Workshop Assessment Follow-up Scale
20 secondary outcomes
Antiretroviral Therapy (ART) Initiation and Adherence
Time frame: Baseline
Antiretroviral Therapy (ART) Initiation and Adherence
Time frame: 6 months post-enrollment
Alcohol Use - self-reported frequency and amount
Time frame: Baseline
Alcohol Use - self-reported frequency and amount
Time frame: 6 months post-enrollment
Alcohol Use
Time frame: Baseline
Alcohol Use
Time frame: 6 months post-enrollment
Substance Use
Time frame: Baseline
Substance Use
Time frame: 6-months post-enrollment
Substance use
Time frame: Baseline
Substance use
Time frame: 6-months post-enrollment
Sexual Risk
Time frame: Baseline
Sexual Risk
Time frame: 6-months post-enrollment
Sexual Risk
Time frame: Baseline
Sexual Risk
Time frame: 6-months post-enrollment
Violence/Victimization
Time frame: Baseline
Violence/Victimization
Time frame: 6-months post-enrollment
Sexual Communication
Time frame: Baseline
Sexual Communication
Time frame: 6-months post-enrollment
Relationship Power
Time frame: Baseline
Relationship Power
Time frame: 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 8 Jan 2025.
- Background: PubMed 28923034Wechsberg WM, Ndirangu JW, Speizer IS, Zule WA, Gumula W, Peasant C, Browne FA, Dunlap L. An implementation science protocol of the Women's Health CoOp in healthcare settings in Cape Town, South Africa: A stepped-wedge design. BMC Womens Health. 2017 Sep 18;17(1):85. doi: 10.1186/s12905-017-0433-8.
- Background: PubMed 29157230Howard BN, Van Dorn R, Myers BJ, Zule WA, Browne FA, Carney T, Wechsberg WM. Barriers and facilitators to implementing an evidence-based woman-focused intervention in South African health services. BMC Health Serv Res. 2017 Nov 21;17(1):746. doi: 10.1186/s12913-017-2669-2.
- Results publication: PubMed 33891233Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Kline TL, Gichane M, Zule WA. Outcomes of Implementing in the Real World the Women's Health CoOp Intervention in Cape Town, South Africa. AIDS Behav. 2021 Dec;25(Suppl 3):276-289. doi: 10.1007/s10461-021-03251-7. Epub 2021 Apr 23.
- Results publication: PubMed 32771909Gichane MW, Wechsberg WM, Ndirangu J, Browne FA, Bonner CP, Grimwood A, Shaikh N, Howard B, Zule WA. Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa. Drug Alcohol Depend. 2020 Oct 1;215:108206. doi: 10.1016/j.drugalcdep.2020.108206. Epub 2020 Aug 1.
- Results publication: PubMed 36344731Browne FA, Gichane MW, Shangase N, Ndirangu J, Bonner CP, Wechsberg WM. Social Determinants of Alcohol and Other Drug Misuse Among Women Living with HIV in Economically Underserved Communities in Cape Town, South Africa: A Cross-Sectional Study. AIDS Behav. 2023 Apr;27(4):1329-1338. doi: 10.1007/s10461-022-03869-1. Epub 2022 Nov 7.
- Results publication: PubMed 34538158Gichane MW, Wechsberg WM, Ndirangu J, Howard B, Bonner CP, Browne FA, Zule WA. Sustainability of a gender-focused HIV and alcohol risk-reduction intervention in usual care settings in South Africa: a mixed methods analysis. AIDS Care. 2021 Jan-Dec;33(sup1):11-17. doi: 10.1080/09540121.2021.1966694. Epub 2021 Sep 19.
- Results publication: PubMed 35060260Ndirangu JW, Gichane MW, Browne FA, Bonner CP, Zule WA, Cox EN, Smith KM, Carney T, Wechsberg WM. 'We have goals but [it is difficult]'. Barriers to antiretroviral therapy adherence among women using alcohol and other drugs living with HIV in South Africa. Health Expect. 2022 Apr;25(2):754-763. doi: 10.1111/hex.13422. Epub 2022 Jan 21.
- Results publication: PubMed 34299897Washio Y, Browne FA, Ndirangu J, Kline TL, Wechsberg WM. Antiretroviral Therapy (ART) Adherence and Prenatal Alcohol Use among Women Who Are Pregnant with HIV in South Africa. Int J Environ Res Public Health. 2021 Jul 13;18(14):7446. doi: 10.3390/ijerph18147446.
- Results publication: PubMed 34110591Wechsberg WM, Browne FA, Bonner CP, Washio Y, Howard BN, van der Drift I. Current Interventions for People Living with HIV Who Use Alcohol: Why Gender Matters. Curr HIV/AIDS Rep. 2021 Aug;18(4):351-364. doi: 10.1007/s11904-021-00558-x. Epub 2021 Jun 10.
- Individual participant dataSharing planned: Yes
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women's Health CoOp (WHC) in people with HIV and Substance Abuse, run by RTI International at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 sites in United States, 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?
Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (time frame: Baseline). The study lists 16 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 NCT02733003, which also lists 9 linked publications.
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.