Improve PrEP choice and use for Ugandan women through couples-based decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a hybrid type 1 study that blends effectiveness and implementation research to refine and test CUPID, a couples-based shared decision-making intervention for PrEP. It will be delivered in both community and public health clinic settings in Uganda where PrEP choices are offered. The study will evaluate whether CUPID increases PrEP uptake, persistence, and adherence among women, while also examining feasibility, acceptability, and other implementation outcomes. The research engages PrEP delivery staff, peer navigators, women, and their partners across multiple health facilities and community catchment areas. If successful, CUPID could provide a scalable approach to involve male partners in PrEP decision-making and HIV prevention for women.

Why it matters

Who can join: the full rules

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

Where it's running

• Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
  Kampala, Uganda Recruiting

Study contacts

• Principal investigator: Brenda Gati Mirembe, MBChB, MSc — Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.