Depression, Human Immunodeficiency Virus, Sexually Transmitted Diseases
Conditions
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 12 months | 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. |
| Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae | 12 months | 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). |
| Number of Participants Engaged In Vaginal Sex | 12 months | We 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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,758 |
Baseline characteristics
| Characteristic | Intervention - Adolescents | Control - Adolescents | Intervention - Parents | Control - Parents | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 435 Participants | 444 Participants | 435 Participants | 444 Participants | 1758 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV Positive Status | 0 Participants | 2 Participants | — | — | 2 Participants |
| Race/Ethnicity, Customized Race Black African | 404 Participants | 409 Participants | 404 Participants | 409 Participants | 1626 Participants |
| Race/Ethnicity, Customized Race Coloured | 12 Participants | 6 Participants | 12 Participants | 6 Participants | 36 Participants |
| Race/Ethnicity, Customized Race Indian or Asian | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Missing | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 15 Participants | 8 Participants | 15 Participants | 46 Participants |
| Race/Ethnicity, Customized Race White | 8 Participants | 10 Participants | 8 Participants | 10 Participants | 36 Participants |
| Region of Enrollment South Africa | 435 Participants | 444 Participants | 435 Participants | 444 Participants | 1758 Participants |
| Sex/Gender, Customized Gender Boy | 186 Participants | 192 Participants | 0 Participants | 0 Participants | 378 Participants |
| Sex/Gender, Customized Gender Girl | 233 Participants | 237 Participants | 0 Participants | 0 Participants | 470 Participants |
| Sex/Gender, Customized Gender Missing | 2 Participants | 1 Participants | 435 Participants | 444 Participants | 882 Participants |
| Sex/Gender, Customized Gender Trans | 14 Participants | 14 Participants | 0 Participants | 0 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 435 | 0 / 444 | 0 / 435 | 0 / 444 |
| other Total, other adverse events | 0 / 435 | 0 / 444 | 0 / 435 | 0 / 444 |
| serious Total, serious adverse events | 0 / 435 | 0 / 444 | 0 / 435 | 0 / 444 |
Outcome results
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Depressive Symptoms | 18 score on a scale |
| Control | Depressive Symptoms | 22 score on a scale |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants Engaged In Vaginal Sex | Number of participants who had vaginal sex | 216 Participants |
| Intervention | Number of Participants Engaged In Vaginal Sex | Number of participants who used condoms in their last encounter of vaginal sex | 141 Participants |
| Control | Number of Participants Engaged In Vaginal Sex | Number of participants who used condoms in their last encounter of vaginal sex | 166 Participants |
| Control | Number of Participants Engaged In Vaginal Sex | Number of participants who had vaginal sex | 280 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae | 60 Participants |
| Control | Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae | 70 Participants |