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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Frequency of acquired drug resistance mutations among youth failing ART. Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy 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 Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations). 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

Official Title
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The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Peer Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Support Intervention<br>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. | Behavioral: Peer Support<br> <br> |
| No Intervention: Standard of Care Practice<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Virologic suppression | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of acquired drug resistance mutations among youth failing ART. | drug resistance mutations | 2 years | 
| Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy | psychological distress | 2 years | 
| 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 | psychological distress | 2 years | 
| Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations). | (viral load), DBS and hair (tenofovir concentrations). | 2 years | 
| Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques. | detection of drug resistance | 2 years |