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Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

∙ All Aims:

• Able and willing to provide written informed consent

• Fluent in English or the dominant language spoken in the health facility's region.

∙ Aim 1:

• Age ≥18 years

• Meets one of the following criteria:

‣ Performs tasks related to PrEP outreach and/or delivery in former CATALYST study areas. This may include clinic and non-clinic positions.

⁃ Is a member of one of the three regional CATALYST CABs

• Willing to participate in a focus group discussion

∙ Aim 2:

• Aged 18 years or older

• Attending a PrEP follow-up visit

• Able and willing to complete all study procedures.

∙ Aim 3:

• Age ≥18 years

• Meets one of the following criteria:

‣ CUPID couples' decision tool user

⁃ A CUPID intervention provider (member of a CHT or other PrEP Provider)

⁃ A provider offering PrEP choice through a health facility where CUPID is implemented

⁃ MOH or District Health Official

• Willing to complete a questionnaire and participate in a qualitative interview (individual or dyadic)

Locations
Other Locations
Uganda
Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
RECRUITING
Kampala
Time Frame
Start Date: 2026-05-13
Estimated Completion Date: 2028-03
Participants
Target number of participants: 1424
Treatments
Experimental: CUPID shared decision-making counseling intervention
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, National Institute of Mental Health (NIMH), MU-JHU CARE
Leads: RTI International

This content was sourced from clinicaltrials.gov