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

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

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 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• MU-JHU CARE

  collaborator OTHER

• University of Washington

  collaborator OTHER

• RTI International

  lead OTHER

Principal Investigators

• Brenda Gati Mirembe, MBChB, MSc · Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD

• Carolyne A Akello, MBChB, MSc · MU-JHU Research Collaboration/ Ministry of Health

• Alexandra M Minnis, PhD, MPH · RTI International

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-13

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• Uganda

Study Locations