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

14. maj 2026 opdateret af: Alexandra Minnis, RTI International
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1424

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Uganda
      • Kampala, Uganda
        • Rekruttering
        • Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
        • Kontakt:
          • Dr. Brenda Gati Mirembe, MBChB, MSc
          • Telefonnummer: (+256) 200 404 100
          • E-mail: bgati@mujhu.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CUPID shared decision-making counseling intervention
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PrEP persistence
Tidsramme: 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
Weekly for 48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PrEP uptake
Tidsramme: Weekly for 64 weeks
Number of PrEP initiations by women per week
Weekly for 64 weeks
6-month PrEP persistence
Tidsramme: Weekly for 36 weeks
Number of 6-month PrEP refill/administration visits per week
Weekly for 36 weeks
PrEP use: Objective adherence
Tidsramme: 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
Weekly for 48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

RTI International

Samarbejdspartnere

National Institute of Mental Health (NIMH)
University of Washington
MU-JHU CARE

Efterforskere

  • Ledende efterforsker: Brenda Gati Mirembe, MBChB, MSc, Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD
  • Ledende efterforsker: Carolyne A Akello, MBChB, MSc, MU-JHU Research Collaboration/ Ministry of Health
  • Ledende efterforsker: Alexandra M Minnis, PhD, MPH, RTI International

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. maj 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • R01MH137873 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data and data dictionaries will be shared through the NIMH Data Archive.

IPD-delingstidsramme

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-delingsadgangskriterier

Researchers will access to the NIMH Data Archive will be able to access the IPD and supporting information provided.

IPD-deling Understøttende informationstype

  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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