HIVCARESNCT07666139
The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study
A study testing Comprehensive Adherence Resource and Empowerment Support' (CARES) in people with HIV, run by RTI International at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Comprehensive Adherence Resource and Empowerment Support' (CARES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
South Africa1 site
Desmond Tutu Health Foundation
Cape Town
Millicent Atujuna, PhD, +27 825187551, millicent.atujuna@hiv-research.org.za
Millicent Millicent Atujuna, PhD
Zimbabwe1 site
Pangaea Zimbabwe
Harare
Nyaradzo Mavis Mgodi, MBChB, MMed, +263 772264616, nmgodi@uz-ctrc.org
Nyaradzo Mavis Mgodi, PhD
About this study
Official title: 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.
- Conditions
- HIV
- Being tested
- Comprehensive Adherence Resource and Empowerment Support' (CARES)
- Keywords
- PrEP, AGYW, South Africa, Zimbabwe, Effectiveness, Feasibility, Acceptability, Fidelity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Adherence Resource and Empowerment Support' (CARES)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Adherence Resource and Empowerment Support (CARES) | Experimental | 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. Receives: Behavioral: Comprehensive Adherence Resource and Empowerment Support' (CARES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation]
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.
Measured: Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.
Secondary outcomes (1)
Percentage of participants with high PrEP adherence [High PrEP adherence]
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study will use a pragmatic multiple-baseline interrupted time series (ITS) design to compare use of pre-exposure prophylaxis (PrEP) at the clinic level before and after intervention implementation at four sites. Each site will be randomly assigned to a staggered intervention start date, and outcomes will be assessed monthly over 27 months. A 6-month washout period will be included immediately after the intervention start date to allow clients time to participate in the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention before they are included in the intervention delivery period assessments. The primary outcome will be at the clinic-level as the proportion of AGYW per clinic continuing on any PrEP product. The secondary outcome will be the proportion of AGYW per clinic with high adherence to any PrEP product, which will be estimated using a repeat cross-sectional subsample of up to100 participants (25 per facility per month).
- Masking
- None (open label)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Chicago, Pangaea Zimbabwe Aids Trust, Desmond Tutu Health Foundation
- Responsible party
- Principal investigator, Sarah Roberts, RTI International
- Investigators
- Sarah Roberts, PhD, Principal investigator, RTI InternationalMillicent Atujuna, PhD, Principal investigator, Desmond Tutu Health FoundationNyaradzo Mavis Mgodi, MBChB, MMed, Principal investigator, Pangaea Zimbabwe Aids Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666139
- Sponsor's protocol ID
- HREC-020/2025; MRCZ/A/3293
- Other IDs
- R01MH137804
- Acronym
- CARES
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe
- ClinicalTrials.gov ID
- NCT07666139
- Acronym / sponsor ID
- CARES / HREC-020/2025; MRCZ/A/3293
- Conditions
- HIV
- Keywords
- PrEP, AGYW, South Africa, Zimbabwe, Effectiveness, Feasibility, Acceptability, Fidelity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Chicago, Pangaea Zimbabwe Aids Trust, Desmond Tutu Health Foundation
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will use a pragmatic multiple-baseline interrupted time series (ITS) design to compare use of pre-exposure prophylaxis (PrEP) at the clinic level before and after intervention implementation at four sites. Each site will be randomly assigned to a staggered intervention start date, and outcomes will be assessed monthly over 27 months. A 6-month washout period will be included immediately after the intervention start date to allow clients time to participate in the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention before they are included in the intervention delivery period assessments. The primary outcome will be at the clinic-level as the proportion of AGYW per clinic continuing on any PrEP product. The secondary outcome will be the proportion of AGYW per clinic with high adherence to any PrEP product, which will be estimated using a repeat cross-sectional subsample of up to100 participants (25 per facility per month).
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Adherence Resource and Empowerment Support (CARES) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Adherence Resource and Empowerment Support' (CARES)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. | Behavioural | Comprehensive Adherence Resource and Empowerment Support (CARES) |
Primary outcome
Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation]
Time frame: Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.
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.
1 secondary outcome
Percentage of participants with high PrEP adherence [High PrEP adherence]
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for HIV
RecruitingObservational study
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
HIV, Immunodeficiencies
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
Enrolling by invitationObservational study
Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Roberts, PhD principal investigator
RTI International
Millicent Atujuna, PhD principal investigator
Desmond Tutu Health Foundation
Nyaradzo Mavis Mgodi, MBChB, MMed principal investigator
Pangaea Zimbabwe Aids Trust
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Adherence Resource and Empowerment Support' (CARES) in people with HIV, run by RTI International at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Roberts, PhD (+1919-541-6000, sroberts@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation] (time frame: Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.