HIV
Conditions
Keywords
CAB-PrEP, LEN-PrEP, Oral PrEP, PrEP Ring, Uganda, Couples, Decision Tool, PrEP Choice
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.
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
BEHAVIORALCUPID 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
RTI International
National Institute of Mental Health (NIMH)
MU-JHU CARE
University of Washington
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Interrupted Time Series
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP persistence | Weekly for 48 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake | Weekly for 64 weeks | Number of PrEP initiations by women per week |
| 6-month PrEP persistence | Weekly for 36 weeks | Number of 6-month PrEP refill/administration visits per week |
| PrEP use: Objective adherence | Weekly for 48 weeks | 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 |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORBrenda Gati Mirembe, MBChB, MSc
Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD
PRINCIPAL_INVESTIGATORCarolyne A Akello, MBChB, MSc
MU-JHU Research Collaboration/ Ministry of Health
PRINCIPAL_INVESTIGATORAlexandra M Minnis, PhD, MPH
RTI International
Outcome results
None listed