Clinical trial NCT02833441: The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes
Official title: The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of Zimbabwe
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 214
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of acquired drug resistance mutations among youth failing ART.
timeFrame: 2 years
measure: Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).
timeFrame: 2 years
measure: Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.
timeFrame: 2 years
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Parirenyatwa Hospital
Study officials:
affiliation: University of Zimbabwe College of Health Sciences
name: Chiratidzo E Ndhlovu, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ndhlovu CE, Kouamou V, Nyamayaro P, Dougherty L, Willis N, Ojikutu BO, Makadzange AT. The transient effect of a peer support intervention to improve adherence among adolescents and young adults failing antiretroviral therapy in Harare, Zimbabwe: a randomized control trial. AIDS Res Ther. 2021 Jun 16;18(1):32. doi: 10.1186/s12981-021-00356-w.