The Peer Support Intervention – Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes

Overview

Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

Full Title of Study: “The Peer Support Intervention – Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 2018

Detailed Description

Title The Peer Support Intervention – supporting HIV positive adolescents in Zimbabwe to improve HIV care continuum outcomes Short Title The Peer Support Intervention Study Design Prospective randomized study Study Duration 2 years Study Population 250 Youth (ages 10-24 years) with virologic failure Study Outcomes Primary Outcomes 1. Virologic suppression rate in the The Peer Support Intervention group compared with the standard of care group following 48 weeks in the Peer Support Intervention. Secondary Outcomes 1. Frequency of acquired drug resistance mutations among youth failing ART. 2. Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy 3. Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of enrolment in the Peer Support Intervention compared with the standard of care 4. Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations). 5. Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques. Description of Intervention Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression. Study Sites Parirenyatwa Hospital Family Care Centre

Interventions

  • Behavioral: Peer Support

Arms, Groups and Cohorts

  • Experimental: Peer Support Intervention
    • Adolescents/young adults in the Peer Support Intervention arm will be referred to a Peer Support Intervention support group within their own or nearby community. This support group will meet monthly and will be facilitated by a professional HIV counsellor together with a Peer Support Intervention counselor. The Peer Support Intervention counsellors will provide regular counselling to their allocated participants through home visits and SMS messages. Each participant will be visited once a week in their home. Whatsapp messages will be delivered daily to each participant by the Community Adolescent Treatment Supporters. The agreed messages will briefly enquire about the participant’s well-being without specifically making reference to HIV or ARVs. In addition, participants’ caregivers will be invited to a 3-session intervention to build knowledge, skills and confidence to better support their adolescents.
  • No Intervention: Standard of Care Practice
    • Participants in the standard of care group will receive adherence evaluations and counseling at the clinic as per the current standard of care. Current procedures involve a group counseling session given on Monday morning during which topics are discussed that are relevant to adolescents. In general children aged between 13-19 years attend these sessions. After the group counseling, adolescents also receive an individual counseling session before being evaluated by the clinic doctor. Youth are also encouraged to complete a self reported adherence questionnaire and may periodically undergo pill counts by the clinic counselors. The adolescents may belong to peer support groups in their communities, however these activities are not part of the clinic program. No interventions are typically targeted at their caregivers.

Clinical Trial Outcome Measures

Primary Measures

  • Virologic suppression rate in the Peer Support Intervention i group compared with the standard of care group following 48 weeks in the Peer Support Intervention.
    • Time Frame: 2 years
    • Virologic suppression

Secondary Measures

  • Frequency of acquired drug resistance mutations among youth failing ART.
    • Time Frame: 2 years
    • drug resistance mutations
  • Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy
    • Time Frame: 2 years
    • psychological distress
  • Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of enrolment in the Peer Support Intervention compared with the standard of care
    • Time Frame: 2 years
    • psychological distress
  • Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).
    • Time Frame: 2 years
    • (viral load), DBS and hair (tenofovir concentrations).
  • Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.
    • Time Frame: 2 years
    • detection of drug resistance

Participating in This Clinical Trial

Inclusion Criteria

  • Documented HIV positive – Age > 10 years and ≤ 24 years – Two consecutive HIV VL>400 copies/mL, at least one month apart – Residence within 50 km of Harare – Able to provide written informed consent (age 18 or older) or assent (age <18 years) Exclusion Criteria:

  • Inability to provide informed consent or assent – Past or current involvement in the Zvandiri Intervention Program

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zimbabwe
  • Provider of Information About this Clinical Study
    • Principal Investigator: Azure Tariro Makadzange, Lecturer – University of Zimbabwe
  • Overall Official(s)
    • Chiratidzo E Ndhlovu, MBChB, Principal Investigator, University of Zimbabwe College of Health Sciences

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