Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RTI International
- Enrollment
- 1,424
- Locations
- 1
Study Overview
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.
Detailed Description
This is a hybrid type 1 effectiveness-implementation study designed to refine, evaluate effectiveness, and assess implementation of a couples-based shared decision-making intervention (CUPID) within public health settings where HIV pre-exposure prophylaxis (PrEP) choice is offered to women in Uganda. The following are the aims of the study:
Aim 1: Refine CUPID intervention content and implementation to support women's PrEP choice and use in public health settings.
Aim 2: Assess the effectiveness of the CUPID intervention on PrEP use (uptake, persistence, and adherence) among Ugandan women.
Aim 3: Assess CUPID intervention implementation outcomes, and barriers and strategies to address them, to inform the adoption and integration of CUPID to support women's PrEP uptake and use.
The study population will include (Aim 1): PrEP delivery staff, Peer navigators & stakeholders; and (Aims 2 and 3): Women accessing PrEP and their sexual partners; PrEP delivery staff.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Able and willing to provide written informed consent
- •Fluent in English or the dominant language spoken in the health facility's region.
- •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
- •Aged 18 years or older
- •Attending a PrEP follow-up visit
- •Able and willing to complete all study procedures.
- •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)
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.
- •Exclusion criteria: Participants aged 15-17 years
Investigators
Alexandra Minnis
Principal Investigator; Director, Public Health
RTI International