The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study (CARES)
23. juni 2026 opdateret af: Sarah Roberts, RTI International
Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe
The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively using various forms of pre-exposure prophylaxis (PrEP), specifically oral, ring, and injectable PrEP.
Originally developed for a clinical trial setting, CARES has shown promising results in enhancing effective PrEP use through a structured mix of counseling, SMS/phone calls, and peer support for daily oral PrEP and the PrEP ring.
However, its resource-intensive design requires adaptation for routine public health settings to ensure feasibility, fidelity, acceptability, and effectiveness.
This adapted intervention will be tailored with input from AGYW, PrEP providers, and local stakeholders to support sustainable PrEP use and address HIV prevention needs among AGYW.
Additionally, it will incorporate injectable PrEP and be modified to suit routine public health contexts.
Once the components are finalized, the adapted CARES intervention will be evaluated for effectiveness, feasibility, fidelity, and acceptability.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
2100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sarah Roberts, PhD
- Telefonnummer: +1919-541-6000
- E-mail: sroberts@rti.org
Studiesteder
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Cape Town, Sydafrika
- Desmond Tutu Health Foundation
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Kontakt:
- Millicent Atujuna, PhD
- Telefonnummer: +27 825187551
- E-mail: millicent.atujuna@hiv-research.org.za
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Ledende efterforsker:
- Millicent Millicent Atujuna, PhD
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Harare, Zimbabwe
- Pangaea Zimbabwe
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Kontakt:
- Nyaradzo Mavis Mgodi, MBChB, MMed
- Telefonnummer: +263 772264616
- E-mail: nmgodi@uz-ctrc.org
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Ledende efterforsker:
- Nyaradzo Mavis Mgodi, PhD
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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
- Barn
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Aim 2:
Inclusion (AGYW):
- age 16-24 years (in Zimbabwe, participants aged 16 to 17 years must meet the legal criteria for emancipation to be eligible)
- has initiated PrEP during the study, or no more than 6 months before the study initiation date (for LEN PrEP), or no more than 3 months before the study initiation date (for oral, ring, or CAB PrEP), and
- willing and able to provide written informed consent for access to medical records, or assent and parental consent if applicable
- fluent in one of the study languages (English, isiXhosa, Shona, Ndebele)
- target date for PrEP resupply (i.e., to ensure continued coverage) falls within the month.
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 |
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Eksperimentel: Comprehensive Adherence Resource and Empowerment Support (CARES)
Each health facility will initially offer standard of care (SOC) adherence counseling, then will transition on a randomly assigned start date to offering the CARES intervention instead of SOC adherence counseling.
Choice of available PrEP methods will be available throughout the study as part of standard of care at the health facilities.
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The CARES intervention includes one-on-one client-centered adherence counseling, objective adherence feedback, and optional support strategies selected according to participant needs and preferences, such as two-way SMS reminders, weekly check-ins, peer buddy support, and adherence clubs.
The final intervention package will be adapted for study implementation during the formative phase of the study.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation]
Tidsramme: Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.
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Percent of AGYW per clinic per month who have received on-time PrEP resupply at all scheduled visits for 3 months after initiation for CAB injection, oral PrEP, and ring or 6 months after initiation for LEN injection.
Measured among those due for resupply visit in that month.
On-time resupply is defined as resupply within a 14-day window of the target date to ensure continuous coverage.
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Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of participants with high PrEP adherence [High PrEP adherence]
Tidsramme: Monthly for a total of 21 months, from the start of the pre-intervention period to the end of the intervention delivery period with a pause during the 6-month washout period after the start of intervention delivery.
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Percent of subsample participants per clinic per month with (1) biomarker TFVdp levels indicating consistent use (≥700 fmol/punch, corresponding to 4 doses per week) for the past 1-2 months; (2) >4mg Dapivirine released from used PrEP rings, indicating consistent use for the past 4 weeks; or (3) clinical records indicating on-time injection of injectable PrEP
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Monthly for a total of 21 months, from the start of the pre-intervention period to the end of the intervention delivery period with a pause during the 6-month washout period after the start of intervention delivery.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sarah Roberts, PhD, RTI International
- Ledende efterforsker: Millicent Atujuna, PhD, Desmond Tutu Health Foundation
- Ledende efterforsker: Nyaradzo Mavis Mgodi, MBChB, MMed, Pangaea Zimbabwe Aids Trust
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 (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
31. oktober 2028
Studieafslutning (Anslået)
31. oktober 2028
Datoer for studieregistrering
Først indsendt
8. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HREC-020/2025; MRCZ/A/3293
- R01MH137804 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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