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Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03231358
Enrollment
1758
Registered
2017-07-27
Start date
2018-11-21
Completion date
2024-07-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Human Immunodeficiency Virus, Sexually Transmitted Diseases

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.

Interventions

Our Family Our Future is a 'selective' behavioral prevention program, designed to address HIV/STI acquisition, sexual risk behavior, and depression among adolescents (ages 14-16) in communities with high HIV prevalence and from families where adolescents and parents already exhibit mild, potentially troublesome, depressive symptoms but do not reach the threshold for further screening for a significant clinical depressive disorder. Participants receive the intervention in a community setting, in a facilitated group format. The intervention is comprised of 3-hour sessions, held weekly for 3 consecutive weeks with an individual family meeting in the third or fourth week depending on family desires.

Sponsors

University of Cape Town
CollaboratorOTHER
Desmond Tutu HIV Foundation
CollaboratorOTHER
Medical Research Council, South Africa
CollaboratorOTHER
Rhode Island Hospital
CollaboratorOTHER
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
14 Years to 16 Years
Healthy volunteers
Yes

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+)

Design outcomes

Primary

MeasureTime frameDescription
Depressive Symptoms12 monthsWe will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale. Scores are summed, and range from 0 to 60. Higher scores correspond with worse depressive symptoms. There are ranges for the severity of depressive symptoms and these are as follows: 0-15: May indicate no or low levels of depressive symptoms. 16 or higher: Suggests a risk for clinically significant depressive symptoms.
Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae12 monthsWe will examine whether the intervention produces reductions in HIV and STI prevalence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae. We report on the prevalence of any HIV or STI (positive for one or more of HIV and/or Chlamydia and/or Neisseria).
Number of Participants Engaged In Vaginal Sex12 monthsWe will examine whether the intervention produces reductions in the number of participants engaged in vaginal sex and condom use.

Countries

South Africa

Participant flow

Participants by arm

ArmCount
Intervention - Adolescents
Participants randomized to the behavioral intervention called Our Family Our Future. These participants will receive an intervention to prevent sexually transmitted infections (STIs) including HIV, Chlamydia trachomatis and Neisseria gonorrhoeae; sexual risk behavior; and depression onset. This is a behavioral intervention delivered in a group setting over 3-4 consecutive weeks.
435
Control - Adolescents
The control arm will receive usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care).
444
Intervention - Parents
Adolescents are the target participants for this study. Parents are assigned into an arm, based on the assignment of their child). Because parents are not the primary target of the study, more minimal information is collected on them.
435
Control - Parents
Adolescents are the target participants for this study. Parents are assigned into an arm, based on the assignment of their child). Because parents are not the primary target of the study, more minimal information is collected on them.
444
Total1,758

Baseline characteristics

CharacteristicIntervention - AdolescentsControl - AdolescentsIntervention - ParentsControl - ParentsTotal
Age, Categorical
<=18 years
435 Participants444 Participants435 Participants444 Participants1758 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
HIV Positive Status0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Race
Black African
404 Participants409 Participants404 Participants409 Participants1626 Participants
Race/Ethnicity, Customized
Race
Coloured
12 Participants6 Participants12 Participants6 Participants36 Participants
Race/Ethnicity, Customized
Race
Indian or Asian
1 Participants3 Participants1 Participants3 Participants8 Participants
Race/Ethnicity, Customized
Race
Missing
2 Participants1 Participants2 Participants1 Participants6 Participants
Race/Ethnicity, Customized
Race
Other
8 Participants15 Participants8 Participants15 Participants46 Participants
Race/Ethnicity, Customized
Race
White
8 Participants10 Participants8 Participants10 Participants36 Participants
Region of Enrollment
South Africa
435 Participants444 Participants435 Participants444 Participants1758 Participants
Sex/Gender, Customized
Gender
Boy
186 Participants192 Participants0 Participants0 Participants378 Participants
Sex/Gender, Customized
Gender
Girl
233 Participants237 Participants0 Participants0 Participants470 Participants
Sex/Gender, Customized
Gender
Missing
2 Participants1 Participants435 Participants444 Participants882 Participants
Sex/Gender, Customized
Gender
Trans
14 Participants14 Participants0 Participants0 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 4350 / 4440 / 4350 / 444
other
Total, other adverse events
0 / 4350 / 4440 / 4350 / 444
serious
Total, serious adverse events
0 / 4350 / 4440 / 4350 / 444

Outcome results

Primary

Depressive Symptoms

We will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale. Scores are summed, and range from 0 to 60. Higher scores correspond with worse depressive symptoms. There are ranges for the severity of depressive symptoms and these are as follows: 0-15: May indicate no or low levels of depressive symptoms. 16 or higher: Suggests a risk for clinically significant depressive symptoms.

Time frame: 12 months

Population: We captured symptom scores using the Center for Epidemiologic Studies Depression Scale. Scores are summed, and range from 0 to 60. Higher scores correspond with worse depressive symptoms. There are ranges for the severity of depressive symptoms and these are as follows:~0-15: May indicate no or low levels of depressive symptoms. 16 or higher: Suggests a risk for clinically significant depressive symptoms.

ArmMeasureValue (MEAN)
InterventionDepressive Symptoms18 score on a scale
ControlDepressive Symptoms22 score on a scale
Primary

Number of Participants Engaged In Vaginal Sex

We will examine whether the intervention produces reductions in the number of participants engaged in vaginal sex and condom use.

Time frame: 12 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants Engaged In Vaginal SexNumber of participants who had vaginal sex216 Participants
InterventionNumber of Participants Engaged In Vaginal SexNumber of participants who used condoms in their last encounter of vaginal sex141 Participants
ControlNumber of Participants Engaged In Vaginal SexNumber of participants who used condoms in their last encounter of vaginal sex166 Participants
ControlNumber of Participants Engaged In Vaginal SexNumber of participants who had vaginal sex280 Participants
Primary

Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae

We will examine whether the intervention produces reductions in HIV and STI prevalence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae. We report on the prevalence of any HIV or STI (positive for one or more of HIV and/or Chlamydia and/or Neisseria).

Time frame: 12 months

Population: We report on the prevalence of infection where the participant is at least positive for 1 HIV and/or STIs.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionPrevalence of HIV and/or Chlamydia and/or Gonorrhoeae60 Participants
ControlPrevalence of HIV and/or Chlamydia and/or Gonorrhoeae70 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026