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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: CUPID shared decision-making counseling intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 1424
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Recruiting
    • Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
    • Contact: Dr. Brenda Gati Mirembe, MBChB, MSc; Phone Number: (+256) 200 404 100; Email: bgati@mujhu.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CUPID shared decision-making counseling intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP uptake	Number of PrEP initiations by women per week	Weekly for 64 weeks
6-month PrEP persistence	Number of 6-month PrEP refill/administration visits per week	Weekly for 36 weeks
PrEP use: Objective adherence	Percentage of adherence objective markers collected at the PrEP refill/administration visit per week demonstrating adherent PrEP use. PrEP refill visits will be 2nd refill visits for oral PrEP, PrEP ring and injectable cabotegravir (~3 months after initiation); 1st refill (at 6 months) for injectable lenacapavir	Weekly for 48 weeks

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: National Institute of Mental Health (NIMH); University of Washington; MU-JHU CARE
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Uganda; Oral PrEP; Couples; PrEP Ring; PrEP Choice; CAB-PrEP; LEN-PrEP; Decision Tool
• Other Study ID Numbers: R01MH137873 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and data dictionaries will be shared through the NIMH Data Archive.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Researchers will access to the NIMH Data Archive will be able to access the IPD and supporting information provided.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No