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

14. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

1424

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CUPID shared decision-making counseling intervention
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

RTI International

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. mai 2026

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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