Supporting Sustained HIV Treatment Adherence After Initiation
SUSTAIN
2 other identifiers
interventional
534
1 country
3
Brief Summary
The investigators will implement a 24-month fractional factorial design study (Aim 1). The investigators will recruit 510 patients initiating antiretroviral therapy (ART) at three City of Cape Town ART clinics. Each patient will have adherence monitored using the Wisepill® electronic adherence monitoring device (EAM). After eligibility has been confirmed, each participant will be randomized to one of 16 experimental conditions. Each condition includes a unique combination of five adherence intervention components. Three of these components focus on identifying individuals with poor adherence, with increasing degrees of sophistication, with immediate linkage to adherence support. Two components focus on supporting good adherence. They both supplement the existing adherence support program delivered at the study clinics operated by City of Cape Town (standard of care component). Based on Self-Determination Theory, the investigators postulate these intervention components will: 1) enhance feelings of autonomy support, social support, and knowledge; 2) improve motivation and self-competence; and 3) increase ART retention, adherence, and viral suppression. A subset of the participants, as well as clinic staff, will be invited to in-depth interviews to explore mediating factors (Aim 1) and the implementation process (Aim 2); and the data collected in Aims 1 and 2 will be used to explore cost effectiveness (Aim 3).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Mar 2022
Longer than P75 for not_applicable hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 10, 2021
CompletedStudy Start
First participant enrolled
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJune 10, 2026
June 1, 2026
4.2 years
September 1, 2021
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV viral suppression at 24 months
This outcome will measure the effect of the interventions on HIV viral suppression from enrollment to the end of study participation. HIV viral suppression will be defined as % plasma viral load (VL) \<50 copies/mL (dichotomous).
24 months
Secondary Outcomes (6)
HIV viral suppression at 12 months
12 months
Change in HIV viral load between baseline and 12 months
baseline, 12 months
Change in HIV viral load between baseline and 24 months
baseline, 24 months
Days of unsuppressed virus between baseline and 24 months
baseline, 24 months
Achievement of ≥ 90% adherence in month 24
month 24
- +1 more secondary outcomes
Study Arms (16)
Condition 1
EXPERIMENTALIncludes 1 intervention: S2/Peer: Enhanced peer group support.
Condition 2
EXPERIMENTALIncludes 1 intervention: S1/Text: Weekly check-in text messages.
Condition 3
EXPERIMENTALIncludes 1 intervention: M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient.
Condition 4
EXPERIMENTALIncludes 3 interventions: M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
Condition 5
EXPERIMENTALIncludes 1 intervention: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient.
Condition 6
EXPERIMENTALIncludes 3 interventions: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
Condition 7
EXPERIMENTALIncludes 3 interventions: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
Condition 8
EXPERIMENTALIncludes 3 interventions: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
Condition 9
EXPERIMENTALIncludes 1 intervention: M1/OTR: Outreach (OTR) to patient due to unsuppressed VL test result.
Condition 10
EXPERIMENTALIncludes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
Condition 11
EXPERIMENTALIncludes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
Condition 12
EXPERIMENTALIncludes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
Condition 13
EXPERIMENTALIncludes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S2/Peer: Enhanced peer group support.
Condition 14
EXPERIMENTALIncludes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S1/Text: Weekly check-in text messages.
Condition 15
EXPERIMENTALIncludes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient.
Condition 16
EXPERIMENTALIncludes 5 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
Interventions
Subject will receive an enhanced form of peer group support. Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version. "Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor). There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
The subject will be contacted if he/she fails to collect medication from the pharmacy. A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support. There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter. Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend. For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support. There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics. Subjects will be sent weekly simple but supportive text messages e.g. "how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Eligibility Criteria
You may qualify if:
- Adults (≥18 years) and adolescents 16-17 years.
- HIV-positive and attending a local City of Cape Town (COCT) clinic to commence ART.
- Able to provide full informed consent, with a written signature. For those who are illiterate, a witness will be present throughout the process and will sign the form, while the participant will add their right thumb print. For those who are aged 16-17 years, informed written assent will be obtained, and the adolescent must have a parent or guardian who can provide full informed consent (see \*\*below for how parent/guardian is defined for this purpose).
- Access to a working cellphone and willingness to receive study-related messaging on that phone.
- Willingness to comply with study procedures, including providing regular updates of contact details /locator information, and use a EAM device for the duration of participation.
- Aim 1: In-depth interviews (IDIs) with subset of trial subjects at baseline and months 12 and 24.
- Participation in the main trial.
- Self-reported prior experience with substance use, depression, gender inequity, stigma, or transport/clinic issues.
- Aim 2: Questionnaires and IDIs with staff members at study clinics (three total clinics).
- Adults (≥18 years)
- Staff at study clinics, providing HIV care and/or treatment.
- Aim 2: Focus group discussion (FGD) with City of Cape Town officials.
- Adults (≥18 years)
- Staff at City of Cape Town.
You may not qualify if:
- Clinical conditions as assessed by the COCT clinic clinicians at first visit e.g. renal disease, which preclude the use of a single tablet regimen (with the exception of those on tuberculosis (TB) treatment who are required to take an extra dose of dolutegravir daily).
- Planning to leave Cape Town permanently within the next 24 months.
- Being perinatally infected with HIV. Being infected from birth typically means a set of experiences and complications at a young age that require unique and special attention.
- If an adolescent, taking their ART medication as a syrup, as they are required to use the electronic adherence monitor (Wisepill device), which is only suitable for tablets.
- Aim 1: IDIs with trial subjects.
- None.
- Aim 2: Questionnaires and IDIs with staff members at clinics. • None.
- Aim 2: FGD with City of Cape Town officials.
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- New York Universitycollaborator
- Boston Universitylead
- Desmond Tutu HIV Foundationcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (3)
Mzamomhle
Cape Town, Western Cape, South Africa
Phumlani
Cape Town, Western Cape, South Africa
Weltevreden Valley
Cape Town, Western Cape, South Africa
Related Publications (1)
Jennings L, West RL, Halim N, Kaiser JL, Gwadz M, MacLeod WB, Gifford AL, Haberer JE, Orrell C, Sabin LL. Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa-a multiphase optimization strategy (MOST) approach using a fractional factorial design. Trials. 2023 May 5;24(1):310. doi: 10.1186/s13063-023-07322-z.
PMID: 37147725DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lora Sabin, PhD, MA
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2021
First Posted
September 10, 2021
Study Start
March 9, 2022
Primary Completion
May 28, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
We have not yet made a detailed plan, but tentatively, we will deposit de-identified IPD in a repository at Boston University (BU) School of Public Health and the Desmond Tutu Health Foundation that can be made available to other researchers once our planned analyses are complete.