Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach
ConditionHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRTI International
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Performs tasks related to PrEP outreach and/or delivery in former CATALYST study areas. This may include clinic and non-clinic positions.
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
CUPID shared decision-making counseling intervention
BehavioralThe 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.
Treatment groups
1,424 Participants
are divided into 1 treatment groupGroup A: CUPID shared decision-making counseling interventionExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Weekly for 48 weeksSecondary outcomes
1
PrEP uptake
Number of PrEP initiations by women per week
Time frame
Weekly for 64 weeks2
6-month PrEP persistence
Number of 6-month PrEP refill/administration visits per week
Time frame
Weekly for 36 weeks3
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
Time frame
Weekly for 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
RTI International
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
MU-JHU CARE
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov