Clinical trial NCT03231358: Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Official title: Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus
Depression
Sexually Transmitted Diseases
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: Desmond Tutu HIV Foundation
name: Medical Research Council, South Africa
name: Rhode Island Hospital
First posted: 2017-07-27
Enrollment: 1758
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize adolescents to an intervention arm (testing Our Family Our Future, n=440) or a control arm (n=440) of usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care). We will randomize based on permuted blocked randomization.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the efficacy of Our Family Our Future, an integrated intervention for preventing HIV and depression onset among adolescents.

Detailed description: Adolescent human immunodeficiency virus (HIV) and depression present significant public health challenges for South Africa, a country with the largest HIV epidemic globally and where structural factors including violence and poverty increase susceptibility for poor mental health. In families already experiencing psychological distress, adolescents face elevated risk for sexually transmitted infections (STIs) including HIV and depression. Preventive interventions are urgently needed during adolescence when risks for HIV, STIs, and depression in-crease exponentially. Preventive intervention strategies for adolescents should substantively involve families who can tailor prevention content to meet the unique needs of individual adolescents and reinforce formation and habituation of prevention behaviors. Moreover, evidence indicates common family risk and protective factors for adolescent HIV/STI risk behaviors and depression, underscoring the need for a family prevention approach. However, key gaps exist in family prevention science. In South Africa, few empirically supported family interventions integrate prevention of HIV/STI with depression for adolescents. This intervention (called Our Family Our Future) uses a resilience-oriented approach engages families in adolescent prevention from low-resource settings facing high adversity. The study will focus on adolescents (14-16 years) who are at an ideal developmental transition for family engagement in prevention. The age- and developmentally-tailored intervention - called Our Family Our Future - is based off of two empirically supported interventions that have been integrated and adapted to South Africa. In a pilot randomized trial, Our Family Our Future exhibited outstanding acceptability, feasibility and promising direction of effects including reductions of depressive symptoms; lower rates of sex; decreased unprotected sex; increased HIV testing; increased knowledge, motivation, intentions and self-efficacy for protective HIV/STI behaviors; improved family interactions; and increased resilience. Now investigators propose the next phase of this research program, an efficacy study of Our Family Our Future with three aims: (1) test the efficacy of the Our Family Our Future intervention in preventing HIV/STI acquisition among adolescents (14-16) with depressive symptoms by reducing HIV/STI risk behavior, and reducing depressive symptoms. The project will randomize N=880 adolescents to Our Family Our Future intervention or usual care with 6- and 12-month outcome assessments; (2) examine the extent to which the impact of the Our Family Our Future intervention is a) mediated by changes in resilience; behavioral skills; norms and attitudes relating to sex, condom use, gender; and family communication and functioning and b) moderated by the effect of sociodemographics, family HIV, and social protections; (3) identify barriers and facilitators to implementing Our Family Our Future within a large community-based organization setting with wide reach to provide data for future dissemination and scale-up.

Eligibility criteria: Inclusion Criteria:

* 14-16 years
* adolescent concurs that the adult identified is their parent (to also include primary caregivers in the pa-rental role)
* when more than one child in the family falls within the eligible age range, one child will be chosen at random
* lives in the household at least 4 days a week

Exclusion Criteria:

* no or low symptoms (\<6) or clinically significant thresholds of depression (16+)

Primary outcomes:
measure: Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae
timeFrame: 12 months
measure: Number of Participants Engaged In Vaginal Sex
timeFrame: 12 months
measure: Depressive Symptoms
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Masiphumelele
state: Western Cape
Study officials:
affiliation: Brown University
name: Caroline Kuo, DPhil, MPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Desmond Tutu HIV Foundation
name: Linda-Gail Bekker, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Dan J Stein, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: