NCT07574619 Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach
| NCT ID | NCT07574619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RTI International |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,424 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,424 participants in total. It began in 2026-05-13 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research will evaluate the effectiveness and implementation of a couples shared decision-making intervention, CUPID (Couples United in HIV Prevention Informed Decisions), delivered in community and clinic settings to support women's pre-exposure prophylaxis (PrEP) choice and use through male partner support and shared decision-making. Through a partnership with Ministry of Health clinics already providing choices for PrEP in Uganda, the investigators will evaluate whether CUPID is effective in increasing PrEP uptake, persistence, and use among Ugandan women and assess implementation outcomes to determine whether it is acceptable and feasible to implement. If successful, CUPID will offer a community-based strategy for engaging male partners to support PrEP choice and improve HIV prevention among women and provide a scalable and sustainable intervention that will contribute to a more comprehensive approach to HIV prevention.
Eligibility Criteria
Inclusion Criteria: All Aims: 1. Able and willing to provide written informed consent 2. Fluent in English or the dominant language spoken in the health facility's region. Aim 1: 1. Age ≥18 years 2. Meets one of the following criteria: 1. Performs tasks related to PrEP outreach and/or delivery in former CATALYST study areas. This may include clinic and non-clinic positions. 2. Is a member of one of the three regional CATALYST CABs 3. Willing to participate in a focus group discussion Aim 2: 1. Aged 18 years or older 2. Attending a PrEP follow-up visit 3. Able and willing to complete all study procedures. Aim 3: 1. Age ≥18 years 2. Meets one of the following criteria: 1. CUPID couples' decision tool user 2. A CUPID intervention provider (member of a CHT or other PrEP Provider) 3. A provider offering PrEP choice through a health facility where CUPID is implemented 4. MOH or District Health Official 3. Willing to complete a questionnaire and participate in a qualitative interview (individual or dyadic) Exclusion Criteria: All Aims: Participants will be excluded who have any condition that, in the opinion of the MPI or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. Aim 2: Exclusion criteria: Participants aged 15-17 years
Contact & Investigator
Brenda Gati Mirembe, MBChB, MSc
PRINCIPAL INVESTIGATOR
Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD
Frequently Asked Questions
Who can join the NCT07574619 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07574619 currently recruiting?
Yes, NCT07574619 is actively recruiting participants. Visit ClinicalTrials.gov or contact RTI International to inquire about joining.
Where is the NCT07574619 trial being conducted?
This trial is being conducted at Kampala, Uganda.
Who is sponsoring the NCT07574619 clinical trial?
NCT07574619 is sponsored by RTI International. The principal investigator is Brenda Gati Mirembe, MBChB, MSc at Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD. The trial plans to enroll 1,424 participants.
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