Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach (CUPID)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kampala, Uganda
- Reclutamento
- Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care
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Contatto:
- Dr. Brenda Gati Mirembe, MBChB, MSc
- Numero di telefono: (+256) 200 404 100
- Email: bgati@mujhu.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
All Aims:
- Able and willing to provide written informed consent
- Fluent in English or the dominant language spoken in the health facility's region.
Aim 1:
- Age ≥18 years
Meets one of the following criteria:
- Performs tasks related to PrEP outreach and/or delivery in former CATALYST study areas. This may include clinic and non-clinic positions.
- Is a member of one of the three regional CATALYST CABs
- Willing to participate in a focus group discussion
Aim 2:
- Aged 18 years or older
- Attending a PrEP follow-up visit
- Able and willing to complete all study procedures.
Aim 3:
- Age ≥18 years
Meets one of the following criteria:
- CUPID couples' decision tool user
- A CUPID intervention provider (member of a CHT or other PrEP Provider)
- A provider offering PrEP choice through a health facility where CUPID is implemented
- MOH or District Health Official
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: CUPID shared decision-making counseling intervention
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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PrEP persistence
Lasso di tempo: Weekly for 48 weeks
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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
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Weekly for 48 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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PrEP uptake
Lasso di tempo: Weekly for 64 weeks
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Number of PrEP initiations by women per week
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Weekly for 64 weeks
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6-month PrEP persistence
Lasso di tempo: Weekly for 36 weeks
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Number of 6-month PrEP refill/administration visits per week
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Weekly for 36 weeks
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PrEP use: Objective adherence
Lasso di tempo: Weekly for 48 weeks
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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
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Weekly for 48 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Brenda Gati Mirembe, MBChB, MSc, Makerere University-Johns Hopkins Research Collaboration /MU-JHU CARE LTD
- Investigatore principale: Carolyne A Akello, MBChB, MSc, MU-JHU Research Collaboration/ Ministry of Health
- Investigatore principale: Alexandra M Minnis, PhD, MPH, RTI International
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- R01MH137873 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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