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

NCT07574619 | Not Yet Recruiting DMC

• 1 other identifier: R01MH137873
• Study Type: interventional
• Target: 1,424
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

CAB-PrEP; LEN-PrEP; Oral PrEP; PrEP Ring; Uganda; Couples; Decision Tool; PrEP Choice

Outcome Measures

Primary Outcomes (1)

• PrEP persistence

  Number of PrEP refill/administration visits by women per week: 2nd refill visits for oral PrEP, PrEP ring and injectable cabotegravir (\~3 month persistence); 1st refill (at 6 months) for injectable lenacapavir

  Weekly for 48 weeks

Secondary Outcomes (3)

• PrEP uptake

  Weekly for 64 weeks

• 6-month PrEP persistence

  Weekly for 36 weeks

• PrEP use: Objective adherence

  Weekly for 48 weeks

Study Arms (1)

CUPID shared decision-making counseling intervention

EXPERIMENTAL

Behavioral: CUPID shared decision-making counseling intervention

Interventions

CUPID shared decision-making counseling intervention BEHAVIORAL

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 Health Teams, or other personnel affiliated with MOH clinics trained to operate in communities), with onsite support, as needed, from a PrEP delivery staff, counselors, or other health providers. The CUPID shared decision-making model provides a patient-centered approach to encourage an informed and active role in decision making by providing couples with knowledge about the available options and helping to clarify their needs and values relevant to the decision.

CUPID shared decision-making counseling intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological males and females and males; only cisgender men and women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• RTI International: lead
• National Institute of Mental Health (NIMH): collaborator
• MU-JHU CARE: collaborator
• University of Washington: collaborator

Study Sites (1)

Makerere University-Johns Hopkins University Research Collaboration

Kampala, Uganda

Location

Study Officials

• Brenda Gati Mirembe, MBChB, MSc

  Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD

  PRINCIPAL INVESTIGATOR

• Carolyne A Akello, MBChB, MSc

  MU-JHU Research Collaboration/ Ministry of Health

  PRINCIPAL INVESTIGATOR

• Alexandra M Minnis, PhD, MPH

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Director, Public Health

Model Details: Interrupted Time Series

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: IPD will be uploaded to the NIMH Data Archive twice per year and will be made publicly available at the end of the study period.
• Access Criteria: Researchers will access to the NIMH Data Archive will be able to access the IPD and supporting information provided.

Locations

UG (1)