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

Overview

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.

Sites will be drawn from high-volume health facilities providing PrEP choice in Uganda, including Gulu Regional Referral Hospital, Namakwekwe Health Centre III, Kitgum Hospital, Bison Health Centre III, Mukono Hospital and Wakiso Health Center IV. Sites will include health facilities and the community catchment areas where services are delivered.

The CUPID decision tool offers a patient-centered approach to encourage an informed and active role in decision making by providing couples with knowledge about available PrEP options, encouraging shared responsibility for HIV prevention, and helping to clarify their needs and values relevant to prevention decisions.

Interventions

• Behavioral CUPID shared decision-making counseling intervention
  The CUPID shared decision-making counseling intervention involves delivery of a paper-based, shared decision-making tool in community and clinic settings by PrEP delivery staff and Community Health Teams affiliated with each health facility. The intervention is designed as a single session in which a couple will go through the decision tool, guided by a trained member of a Community Health Team (which can include Community Health Extension Workers, Peer Educators, PrEP Ambassadors, Village Healt

Primary outcome measures

• PrEP persistence [Time frame: Weekly for 48 weeks]

Secondary outcome measures (3)

• PrEP uptake [Time frame: Weekly for 64 weeks]
• 6-month PrEP persistence [Time frame: Weekly for 36 weeks]
• PrEP use: Objective adherence [Time frame: Weekly for 48 weeks]

Eligibility criteria

Inclusion criteria

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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Prevention

Study locations

Uganda · 1 center

• Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care — Kampala

Identifiers

NCT: NCT07574619 · R01MH137873 · R01MH137873

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗