The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study (CARES)
23. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
2100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sarah Roberts, PhD
- Telefonnummer: +1919-541-6000
- E-post: sroberts@rti.org
Studiesteder
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Cape Town, Sør-Afrika
- Desmond Tutu Health Foundation
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Ta kontakt med:
- Millicent Atujuna, PhD
- Telefonnummer: +27 825187551
- E-post: millicent.atujuna@hiv-research.org.za
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Hovedetterforsker:
- Millicent Millicent Atujuna, PhD
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Harare, Zimbabwe
- Pangaea Zimbabwe
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Ta kontakt med:
- Nyaradzo Mavis Mgodi, MBChB, MMed
- Telefonnummer: +263 772264616
- E-post: nmgodi@uz-ctrc.org
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Hovedetterforsker:
- Nyaradzo Mavis Mgodi, PhD
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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
- Barn
- Voksen
Tar imot friske 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
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 |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sarah Roberts, PhD, RTI International
- Hovedetterforsker: Millicent Atujuna, PhD, Desmond Tutu Health Foundation
- Hovedetterforsker: Nyaradzo Mavis Mgodi, MBChB, MMed, Pangaea Zimbabwe Aids Trust
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 (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. oktober 2028
Studiet fullført (Antatt)
31. oktober 2028
Datoer for studieregistrering
Først innsendt
8. juni 2026
Først innsendt som oppfylte QC-kriteriene
18. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HREC-020/2025; MRCZ/A/3293
- R01MH137804 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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