Supporting Sustained HIV Treatment Adherence After Initiation

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).

Conditions

• HIV Infections
• Adherence, Medication

Interventions

BEHAVIORAL

M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result

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.

BEHAVIORAL

M2/PRM: Immediate outreach to subject after a missed pharmacy refill

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.

BEHAVIORAL

M3/EAM: Immediate outreach to subject after EAM-identified missed doses

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.

BEHAVIORAL

S1/Text: Weekly check-in texts

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.

BEHAVIORAL

S2/Peer: Enhanced peer group support

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.

Sponsors & Collaborators

• Desmond Tutu HIV Foundation

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• New York University

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Boston University

  lead OTHER

Principal Investigators

• Lora Sabin, PhD, MA · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-09

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• South Africa

Study Locations