Condomless SexNCT02974998
Cape Town Young Women's Health CoOp
A study testing Young Women's Health CoOp (YWHC) and Standard HTC in people with Condomless Sex and Human Immunodeficiency Virus (HIV), run by RTI International at 1 site in South Africa.
Trial summary
This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program and targeted female adolescents (aged 16-19) who use substances and have dropped out of school. Read more about this study
- Who is it for?
- Ages 16 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs)
- What is being tested?
- Young Women's Health CoOp (YWHC) and Standard HTC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2016to 26 Nov 2019
- 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 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Self-identify as living in one of the 24 targeted disadvantaged communities
- Between 16 and 19 years old
- Has dropped out of school for at least 6 months
- Is currently dropped out of school
- Has not completed matric (high school diploma) or have an N3 Certificate (South Africa National Technical Certificate)
Show all 10Show fewer
- Reports consuming 2-3 alcoholic drinks at least once in the last 30 days or using illicit drugs at least once a week.
- Reports unprotected sex with a male partner in the last 90 days
- Is able to provide informed assent to participate or informed consent if emancipated or 18 years old
- Has lived in targeted community for at least 6 months and plans to reside in the target community for the next year and provide verifiable locator information
Who cannot join
- Participant must be able to pass a cognitive test
Trial locations and contacts
1 site in 1 country.
South Africa1 site
The South African Medical Research Council (SAMRC),
Cape Town, 7501
About this study
Official title: Expanding HIV Testing and Prevention to Reach Vulnerable Young Women
This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program and targeted female adolescents (aged 16-19) who use substances and have dropped out of school. To evaluate the process, the study examined the feasibility of using peer role models as recruiters and co-facilitators of the intervention and monitored fidelity to the intervention. Efficacy of the intervention on behavioral and biological outcomes, and on linkages to health services, through follow-up visits conducted 6- and 12-months post-enrollment was also assessed.
Read the detailed description
The purpose of this study was to test a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program in 24 disadvantaged communities in Cape Town, South Africa. The researchers conducted community-level randomization across the 24 communities with balanced recruitment from predominantly Black African and predominantly Coloured communities. The aims of the study were: Aim 1. To train and evaluate adolescent peer role models to conduct community outreach with established outreach workers to recruit 500 out-of-school, substance-using female adolescents aged 16 to 19 for HIV testing and counseling (HTC) and to co-facilitate a gender-focused comprehensive HTC program. Aim 2. To test the efficacy of a young women's gender-focused comprehensive HTC program for reducing substance use, victimization, and sexual risk behavior (primary outcomes) and improving access to effective treatment and support services through linkages to care (substance abuse treatment, HIV, sexually transmitted infections [STIs], antenatal and reproductive health as secondary outcomes) relative to standard HTC for adolescent females. The Young Women's Health CoOp has been adapted from the South African Women's Health CoOp (WHC) and the North Carolina Young Women's CoOp (YWC) which was found acceptable in focus groups and maintained all the core elements of the evidence-based intervention. For this study, the intervention was co-facilitated by trained staff from the local communities. The intervention consisted of two 1.5-hour group workshops (sessions), each having several modules that are usually administered a week apart: Workshop 1: Developmental Issues and Alcohol and Other Drugs; Gender, Problem-Solving and Conflict Negotiation, Violence and Values and Becoming a Powerful Young Woman: and Workshop 2: STIs, HIV/AIDS, Prevention, Condoms and Role-play. After each session, each participant developed a risk-reduction personalized action plan (PAP). To maintain PAP goals and reduce decay of intervention effects over time, the staff conducted case management to help participants attain these personal goals. Participants completed baseline, 6-month follow-up and 12-month follow-up assessments, which included a survey and biological testing for substance use, pregnancy and HIV.
- Conditions
- Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs), Alcohol and Drug Use, Violence and Victimization, Access and Linkage to Healthcare
- Being tested
- Young Women's Health CoOp (YWHC), Standard HTC
- Keywords
- Human Immunodeficiency Virus (HIV), HIV Testing and Counseling (HTC), Sexually Transmitted Infections (STIs), Substance Abuse, Gender Based Violence, Gang Violence, Victimization, Linkage to Care, Sexual Risk, Out-of-school Adolescents, Young Women
- Medical subject headings
- Unsafe Sex, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Women's Health CoOp (YWHC)Behavioural
Participants received HTC and engaged in a two-session gender-focused intervention. The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live.
Standard HTCBehavioural
Participants received the standard HTC available in South Africa for this population.
| Study group | Role | What they receive |
|---|---|---|
| Young Women's Health CoOp (YWHC)/ HTC | Experimental | Participants received an enhanced gender-focused HTC intervention. Receives: Behavioral: Young Women's Health CoOp (YWHC) |
| Standard HTC | Active comparator | Participants received the standard HTC available in South Africa for this population. Receives: Behavioral: Standard HTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Sexual Risk
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment)
Measured: Baseline
Reduced Sexual Risk
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
Measured: 6 months after baseline
Reduced Sexual Risk
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
Measured: 12 months after baseline
Increased Condom Use
Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
Measured: Baseline
Increased Condom Use
Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
Measured: 6 months after baseline
Increased Condom Use
Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
Measured: 12 months after baseline
Reduced Alcohol and Illicit Drug Use
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
Measured: Baseline
Reduced Alcohol and Illicit Drug Use
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
Measured: 6 months after baseline
Reduced Alcohol and Illicit Drug Use
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
Measured: 12 months after baseline
Reduced Violence and Victimization
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Measured: Baseline
Reduced Violence and Victimization
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Measured: 6 months after baseline
Reduced Violence and Victimization
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Measured: 12 months after baseline
Secondary outcomes (6)
Increased Access to Health Services
Self-reported use of sexual reproductive health and HIV \& STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
Measured: Baseline
Increased Access to Health Services
Self-reported use of sexual reproductive health and HIV \& STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
Measured: 6 months after baseline
Increased Access to Health Services
Self-reported use of sexual reproductive health and HIV \& STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
Measured: 12 months after baseline
Increased Advancement in Education and Job Training
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Measured: Baseline
Increased Advancement in Education and Job Training
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Measured: 6 months after baseline
Increased Advancement in Education and Job Training
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Condomless SexStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974998
- Sponsor's protocol ID
- R01DA041227
- Status last verified
- Jan 2025
- First submitted
- 23 Nov 2016
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wechsberg WM, Browne FA, Carney T, Myers B, Minnis A, MacDonald R, Ndirangu JW, Turner LB, Howard BN, Rodman N. The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV. BMC Public Health. 2018 Jul 11;18(1):859. doi: 10.1186/s12889-018-5665-5.
PubMed 29996792Bonner CP, Fisher CB, Carney T, Browne FA, Gichane MW, Howard BN, Turner L, Wechsberg WM. "Because all mothers is not the same": The development and implementation of an in loco parentis informed consent procedure to enroll adolescent girls and young women to participate in HIV research. J Adolesc. 2021 Dec;93:234-244. doi: 10.1016/j.adolescence.2021.11.001. Epub 2021 Dec 9.
PubMed 34896961Myers B, Browne FA, Carney T, Kline T, Bonner CP, Wechsberg WM. The Association of Recurrent and Multiple Types of Abuse with Adverse Mental Health, Substance Use, and Sexual Health Outcomes among Out-of-School Adolescent Girls and Young Women in Cape Town, South Africa. Int J Environ Res Public Health. 2021 Oct 29;18(21):11403. doi: 10.3390/ijerph182111403.
PubMed 34769920Bonner CP, Carney T, Browne FA, Ndirangu JW, Howard BN, Wechsberg WM. Substance use and depressive and anxiety symptoms among out-of-school adolescent girls and young women in Cape Town, South Africa. S Afr Med J. 2020 Dec 14;111(1):40-45. doi: 10.7196/SAMJ.2020.v111i1.14520.
PubMed 33404004Bonner CP, Browne FA, Carney T, Shangase N, Ndirangu JW, Myers B, Wechsberg WM. Mandrax use, sexual risk, and opportunities for pre-exposure prophylaxis among out-of-school adolescent girls and young women in Cape Town, South Africa. S Afr Med J. 2022 Apr 29;112(5):341-346.
PubMed 35587247Wechsberg WM, Browne FA, Carney T, Kline TL, Howard BN, Russell SE, van der Drift I, Myers B, Minnis AM, Bonner CP, Ndirangu JW. Outcomes of substance use and sexual power among adolescent girls and young women in Cape Town: Implications for structural and cultural differences. Glob Public Health. 2024 Jan;19(1):2340500. doi: 10.1080/17441692.2024.2340500. Epub 2024 Apr 16.
PubMed 38628080Singer SE, Wechsberg WM, Kline T, Browne FA, Howard BN, Carney T, Myers B, Bonner CP, Chin-Quee D. Binge drinking and condom negotiation behaviours among adolescent girls and young women living in Cape Town, South Africa: sexual control and perceived personal power. BMC Public Health. 2023 Nov 18;23(1):2282. doi: 10.1186/s12889-023-17188-0.
PubMed 37980472
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
- Expanding HIV Testing and Prevention to Reach Vulnerable Young Women
- ClinicalTrials.gov ID
- NCT02974998
- Acronym / sponsor ID
- R01DA041227
- Conditions
- Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs), Alcohol and Drug Use, Violence and Victimization, Access and Linkage to Healthcare
- Keywords
- Human Immunodeficiency Virus (HIV), HIV Testing and Counseling (HTC), Sexually Transmitted Infections (STIs), Substance Abuse, Gender Based Violence, Gang Violence, Victimization, Linkage to Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- Nov 2016
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 29 Nov 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 two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program and targeted female adolescents (aged 16-19) who use substances and have dropped out of school. To evaluate the process, the study examined the feasibility of using peer role models as recruiters and co-facilitators of the intervention and monitored fidelity to the intervention. Efficacy of the intervention on behavioral and biological outcomes, and on linkages to health services, through follow-up visits conducted 6- and 12-months post-enrollment was also assessed.
Detailed description
The purpose of this study was to test a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program in 24 disadvantaged communities in Cape Town, South Africa. The researchers conducted community-level randomization across the 24 communities with balanced recruitment from predominantly Black African and predominantly Coloured communities. The aims of the study were: Aim 1. To train and evaluate adolescent peer role models to conduct community outreach with established outreach workers to recruit 500 out-of-school, substance-using female adolescents aged 16 to 19 for HIV testing and counseling (HTC) and to co-facilitate a gender-focused comprehensive HTC program. Aim 2. To test the efficacy of a young women's gender-focused comprehensive HTC program for reducing substance use, victimization, and sexual risk behavior (primary outcomes) and improving access to effective treatment and support services through linkages to care (substance abuse treatment, HIV, sexually transmitted infections [STIs], antenatal and reproductive health as secondary outcomes) relative to standard HTC for adolescent females. The Young Women's Health CoOp has been adapted from the South African Women's Health CoOp (WHC) and the North Carolina Young Women's CoOp (YWC) which was found acceptable in focus groups and maintained all the core elements of the evidence-based intervention. For this study, the intervention was co-facilitated by trained staff from the local communities. The intervention consisted of two 1.5-hour group workshops (sessions), each having several modules that are usually administered a week apart: Workshop 1: Developmental Issues and Alcohol and Other Drugs; Gender, Problem-Solving and Conflict Negotiation, Violence and Values and Becoming a Powerful Young Woman: and Workshop 2: STIs, HIV/AIDS, Prevention, Condoms and Role-play. After each session, each participant developed a risk-reduction personalized action plan (PAP). To maintain PAP goals and reduce decay of intervention effects over time, the staff conducted case management to help participants attain these personal goals. Participants completed baseline, 6-month follow-up and 12-month follow-up assessments, which included a survey and biological testing for substance use, pregnancy and HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Women's Health CoOp (YWHC)/ HTC | Experimental | Behavioral: Young Women's Health CoOp (YWHC)Participants received an enhanced gender-focused HTC intervention. |
| Standard HTC | Active comparator | Behavioral: Standard HTCParticipants received the standard HTC available in South Africa for this population. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Female
- Self-identify as living in one of the 24 targeted disadvantaged communities
- Between 16 and 19 years old
- Has dropped out of school for at least 6 months
- Is currently dropped out of school
Key exclusion criteria (1 listed)
- Participant must be able to pass a cognitive test
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 |
|---|---|---|
| Young Women's Health CoOp (YWHC)Participants received HTC and engaged in a two-session gender-focused intervention. The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live. | Behavioural | Young Women's Health CoOp (YWHC)/ HTC |
| Standard HTCParticipants received the standard HTC available in South Africa for this population. | Behavioural | Standard HTC |
Primary outcome
Reduced Sexual Risk
Time frame: Baseline
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment)
Reduced Sexual Risk
Time frame: 6 months after baseline
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
Reduced Sexual Risk
Time frame: 12 months after baseline
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
Increased Condom Use
Time frame: Baseline
Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
Increased Condom Use
Time frame: 6 months after baseline
Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
Increased Condom Use
Time frame: 12 months after baseline
Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
Reduced Alcohol and Illicit Drug Use
Time frame: Baseline
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
Reduced Alcohol and Illicit Drug Use
Time frame: 6 months after baseline
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
Reduced Alcohol and Illicit Drug Use
Time frame: 12 months after baseline
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests.
Reduced Violence and Victimization
Time frame: Baseline
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Reduced Violence and Victimization
Time frame: 6 months after baseline
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Reduced Violence and Victimization
Time frame: 12 months after baseline
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
6 secondary outcomes
Increased Access to Health Services
Time frame: Baseline
Increased Access to Health Services
Time frame: 6 months after baseline
Increased Access to Health Services
Time frame: 12 months after baseline
Increased Advancement in Education and Job Training
Time frame: Baseline
Increased Advancement in Education and Job Training
Time frame: 6 months after baseline
Increased Advancement in Education and Job Training
Time frame: 12 months after baseline
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 29996792Wechsberg WM, Browne FA, Carney T, Myers B, Minnis A, MacDonald R, Ndirangu JW, Turner LB, Howard BN, Rodman N. The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV. BMC Public Health. 2018 Jul 11;18(1):859. doi: 10.1186/s12889-018-5665-5.
- Results publication: PubMed 34896961Bonner CP, Fisher CB, Carney T, Browne FA, Gichane MW, Howard BN, Turner L, Wechsberg WM. "Because all mothers is not the same": The development and implementation of an in loco parentis informed consent procedure to enroll adolescent girls and young women to participate in HIV research. J Adolesc. 2021 Dec;93:234-244. doi: 10.1016/j.adolescence.2021.11.001. Epub 2021 Dec 9.
- Results publication: PubMed 34769920Myers B, Browne FA, Carney T, Kline T, Bonner CP, Wechsberg WM. The Association of Recurrent and Multiple Types of Abuse with Adverse Mental Health, Substance Use, and Sexual Health Outcomes among Out-of-School Adolescent Girls and Young Women in Cape Town, South Africa. Int J Environ Res Public Health. 2021 Oct 29;18(21):11403. doi: 10.3390/ijerph182111403.
- Results publication: PubMed 33404004Bonner CP, Carney T, Browne FA, Ndirangu JW, Howard BN, Wechsberg WM. Substance use and depressive and anxiety symptoms among out-of-school adolescent girls and young women in Cape Town, South Africa. S Afr Med J. 2020 Dec 14;111(1):40-45. doi: 10.7196/SAMJ.2020.v111i1.14520.
- Results publication: PubMed 35587247Bonner CP, Browne FA, Carney T, Shangase N, Ndirangu JW, Myers B, Wechsberg WM. Mandrax use, sexual risk, and opportunities for pre-exposure prophylaxis among out-of-school adolescent girls and young women in Cape Town, South Africa. S Afr Med J. 2022 Apr 29;112(5):341-346.
- Derived from this study: PubMed 38628080Wechsberg WM, Browne FA, Carney T, Kline TL, Howard BN, Russell SE, van der Drift I, Myers B, Minnis AM, Bonner CP, Ndirangu JW. Outcomes of substance use and sexual power among adolescent girls and young women in Cape Town: Implications for structural and cultural differences. Glob Public Health. 2024 Jan;19(1):2340500. doi: 10.1080/17441692.2024.2340500. Epub 2024 Apr 16.
- Derived from this study: PubMed 37980472Singer SE, Wechsberg WM, Kline T, Browne FA, Howard BN, Carney T, Myers B, Bonner CP, Chin-Quee D. Binge drinking and condom negotiation behaviours among adolescent girls and young women living in Cape Town, South Africa: sexual control and perceived personal power. BMC Public Health. 2023 Nov 18;23(1):2282. doi: 10.1186/s12889-023-17188-0.
- The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIVLink provided by the sponsor.
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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 Young Women's Health CoOp (YWHC) and Standard HTC in people with Condomless Sex and Human Immunodeficiency Virus (HIV), 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 10 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?
Reduced Sexual Risk (time frame: Baseline). The study lists 12 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 NCT02974998, which also lists 7 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.