Trial Outcomes & Findings for Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa (NCT NCT03231358)
NCT ID: NCT03231358
Last Updated: 2025-05-15
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1758 participants
Primary outcome timeframe
12 months
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
Intervention - Adolescents
Adolescents are the target participants for this study. Adolescent 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.
Our Family Our Future: 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. This intervention is delivered 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.
|
Control - Adolescents
Adolescents are the target participants of this study. Adolescents assigned to 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).
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
435
|
444
|
435
|
444
|
|
Overall Study
COMPLETED
|
391
|
434
|
389
|
432
|
|
Overall Study
NOT COMPLETED
|
44
|
10
|
46
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The target of this intervention was adolescent participants. Thus, minimal information was collected on parent participants, to provide context for change (or lack of) in adolescent participants who are the target of the study/intervention.
Baseline characteristics by cohort
| Measure |
Intervention - Adolescents
n=435 Participants
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.
|
Control - Adolescents
n=444 Participants
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).
|
Intervention - Parents
n=435 Participants
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.
|
Control - Parents
n=444 Participants
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.
|
Total
n=1758 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
435 Participants
n=435 Participants
|
444 Participants
n=444 Participants
|
435 Participants
n=435 Participants
|
444 Participants
n=444 Participants
|
1758 Participants
n=1758 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
0 Participants
n=1758 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
0 Participants
n=1758 Participants
|
|
Sex/Gender, Customized
Gender · Girl
|
233 Participants
n=435 Participants
|
237 Participants
n=444 Participants
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
470 Participants
n=1758 Participants
|
|
Sex/Gender, Customized
Gender · Boy
|
186 Participants
n=435 Participants
|
192 Participants
n=444 Participants
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
378 Participants
n=1758 Participants
|
|
Sex/Gender, Customized
Gender · Trans
|
14 Participants
n=435 Participants
|
14 Participants
n=444 Participants
|
0 Participants
n=435 Participants
|
0 Participants
n=444 Participants
|
28 Participants
n=1758 Participants
|
|
Sex/Gender, Customized
Gender · Missing
|
2 Participants
n=435 Participants
|
1 Participants
n=444 Participants
|
435 Participants
n=435 Participants
|
444 Participants
n=444 Participants
|
882 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Race · Black African
|
404 Participants
n=435 Participants
|
409 Participants
n=444 Participants
|
404 Participants
n=435 Participants
|
409 Participants
n=444 Participants
|
1626 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Race · Coloured
|
12 Participants
n=435 Participants
|
6 Participants
n=444 Participants
|
12 Participants
n=435 Participants
|
6 Participants
n=444 Participants
|
36 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Race · Indian or Asian
|
1 Participants
n=435 Participants
|
3 Participants
n=444 Participants
|
1 Participants
n=435 Participants
|
3 Participants
n=444 Participants
|
8 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
8 Participants
n=435 Participants
|
10 Participants
n=444 Participants
|
8 Participants
n=435 Participants
|
10 Participants
n=444 Participants
|
36 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=435 Participants
|
15 Participants
n=444 Participants
|
8 Participants
n=435 Participants
|
15 Participants
n=444 Participants
|
46 Participants
n=1758 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
2 Participants
n=435 Participants
|
1 Participants
n=444 Participants
|
2 Participants
n=435 Participants
|
1 Participants
n=444 Participants
|
6 Participants
n=1758 Participants
|
|
Region of Enrollment
South Africa
|
435 Participants
n=435 Participants
|
444 Participants
n=444 Participants
|
435 Participants
n=435 Participants
|
444 Participants
n=444 Participants
|
1758 Participants
n=1758 Participants
|
|
HIV Positive Status
|
0 Participants
n=435 Participants • The target of this intervention was adolescent participants. Thus, minimal information was collected on parent participants, to provide context for change (or lack of) in adolescent participants who are the target of the study/intervention.
|
2 Participants
n=444 Participants • The target of this intervention was adolescent participants. Thus, minimal information was collected on parent participants, to provide context for change (or lack of) in adolescent participants who are the target of the study/intervention.
|
—
|
—
|
2 Participants
n=879 Participants • The target of this intervention was adolescent participants. Thus, minimal information was collected on parent participants, to provide context for change (or lack of) in adolescent participants who are the target of the study/intervention.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: We report on the prevalence of infection where the participant is at least positive for 1 HIV and/or STIs.
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).
Outcome measures
| Measure |
Intervention
n=435 Participants
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.
|
Control
n=444 Participants
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).
|
|---|---|---|
|
Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae
|
60 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: 12 monthsWe will examine whether the intervention produces reductions in the number of participants engaged in vaginal sex and condom use.
Outcome measures
| Measure |
Intervention
n=435 Participants
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.
|
Control
n=444 Participants
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).
|
|---|---|---|
|
Number of Participants Engaged In Vaginal Sex
Number of participants who had vaginal sex
|
216 Participants
|
280 Participants
|
|
Number of Participants Engaged In Vaginal Sex
Number of participants who used condoms in their last encounter of vaginal sex
|
141 Participants
|
166 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=435 Participants
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.
|
Control
n=444 Participants
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).
|
|---|---|---|
|
Depressive Symptoms
|
18 score on a scale
Interval 12.0 to 29.0
|
22 score on a scale
Interval 12.0 to 29.0
|
Adverse Events
Intervention - Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention - Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place