Sexual BehaviorPhase 1NCT02432352
Our Family Our Future: Acceptability and Feasibility Study of a Family Prevention Program for HIV Risk and Depression
A Phase 1 study testing Our Family Our Future in people with Sexual Behavior and Depression, run by Brown University at 1 site in South Africa.
Trial summary
The purpose of this study is to assess the feasibility and acceptability of a family-based preventive intervention designed to reduce sexual risk behaviors and depressive symptoms among South African adolescents and their parents/guardians/caregivers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Depression
- What is being tested?
- Our Family Our Future
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2015to 31 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PARENTS/GUARDIANS/CAREGIVERS
- 18+ years
- primary caregiver or the person responsible for childcare in the household on a day to day basis (as identified by the household);
- when more than one primary caregiver exists in the household, one will be chosen at random;
- lives in the household at least 4 days a week
- sub clinical thresholds of depressive symptoms
Show all 12Show fewer
- Adolescent inclusion criteria are:
- 13-15 years;
- concurs that the adult identified is their primary caregiver;
- 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;
- sub clinical thresholds of depressive symptoms
Who cannot join
- PARENTS/GUARDIANS/CAREGIVERS \& Adolescents
- cognitive impairments that would not allow them to provide informed consent or assent;
- if they participated in qualitative phases of the study
- report no or low symptoms or clinically significant thresholds of depression -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Our Family Our Future: Family Prevention of HIV Risk and Depression in HIV-endemic South Africa
The purpose of this study is to assess the feasibility and acceptability of a family-based preventive intervention designed to reduce sexual risk behaviors and depressive symptoms among South African adolescents and their parents/guardians/caregivers.
Read the detailed description
The Our Family Our Future Program is a preventive intervention program designed to prevent or reduce adolescent sexual risk behavior and to increase mental health resilience against depression onset among adolescents (13-15 years of age). The intervention takes a family approach and addresses HIV risk and depression in an integrated model. HIV and depression are the leading causes of global burden of disease in low and middle income countries. The intervention is being tested in South Africa, the country confronting the largest HIV epidemic in the world and because preliminary studies with South African families identified poor mental health and sexual risk behavior as priority areas for preventive intervention development and testing.
This study is a randomized pilot design, where 152 adolescents and parents will be randomly assigned to an intervention condition or a standard usual care condition and then offered the experimental intervention as on a wait-list. Families will be recruited and screened for eligibility based on systematic house-to-house recruitment in the community. Eligibility is based on dyadic eligibility and includes age criteria, consistent presence in the household, depressive symptoms that fall below clinically significant threshold criteria, and ability to provide informed consent and assent. Eligible families will be randomized and offered a preventive intervention program in a group format, led by program facilitators in a community setting. The intervention program consists of 3 sessions plus an individualized family meeting. In some modules parents/guardians/caregivers and adolescents will have content delivered together and in some modules parents/guardians/caregivers and adolescents will break out to adult-only or adolescent-only groups.
The overall objective of study is to assess the following study questions:
Question 1: Is this study feasible? Question 2: Is this intervention acceptable to the target population? Question 3: Is there preliminary evidence of hypothesized effects of the intervention, that the intervention will reduce or maintaining symptoms that fall below the clinically significant range for depression and reduce or delay actual or intended sexual risk behavior in adolescents?
The study takes a single blind, randomized pilot trial. The study takes a secondary prevention approach. The investigators collect three sets of data. First, the investigators assess feasibility by examining recruitment rates, attendance, completion, and drop-out rates, and fidelity. Second, the investigators assess acceptability by examining satisfaction data. Third, as a secondary aim, the investigators use pilot data to assess hypothesized intervention effects by examining outcomes at baseline, immediately post-intervention (2-4 weeks after the last intervention session is completed), and at four months.
- Conditions
- Sexual Behavior, Depression
- Being tested
- Our Family Our Future
- Medical subject headings
- Sexual Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Family Our FutureBehavioural
The Our Family Our Future Program is a family preventive intervention that uses resilience and prevention focused strategies to reduce sexual risk behaviors and build mental wellbeing among adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Families are randomly allocated to a behavioral intervention arm (called Our Family Our Future) focusing on reducing sexual risk behavior in adolescents and reducing or maintaining symptoms that fall below the clinically significant range for depression. Arms will be allocated using urn randomization. Receives: Behavioral: Our Family Our Future |
| Control | No intervention | Families are randomly allocated to the control arm (which receives standard usual care, and then offered the intervention after outcome assessments as a wait-list) using urn randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention
as measured through lifetime and past 3 month sexual acts, condom use, HIV and STI status, prior pregnancy
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change or maintenance of depressive symptoms at sub-clinical range from baseline to 4 months post-intervention measured by CES-D and CES-DC
Self-reported depressive symptoms
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Intervention acceptability - satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options
Measured: acceptability will be assessed during the intervention, an expected average timeframe of 4 weeks
Intervention feasibility measured by attendance, retention for outcome assessments, fidelity
Measured: cceptability will be assessed during the intervention, an expected average timeframe of 4 weeks
Secondary outcomes (20)
Change in resilience from baseline to 4 months post-intervention as measured through CD-RISC
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in depression impairment from baseline to 4 months post-intervention as measured through DISP and CPODMV
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in perceived HIV risk susceptibility from baseline to 4 months post-intervention using a ranking derived from a 0-100 and as measured on a likert scale response
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in HIV knowledge from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in HIV stigma from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in norms and attitudes about sex from baseline to 4 months post-intervention as measured on a likert scale response
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in norms and attitudes about condoms from baseline to 4 months post-intervention as measured through the condom attitudes scale and likert response questions
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in sexual behavior self-efficacy from baseline to 4 months post-interventionusing a ranking derived from a 0-100 and as measured on a likert scale response
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in anxiety from baseline to 4 months post-interventionas measured through BAI and RCMAS
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in psychological distress from baseline to 4 months post-intervention as measured through K6 and SDQ
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in trauma symptoms from baseline to 4 months post-intervention as measured through PCL and NSESSS
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in substance use from baseline to 4 months post-intervention as measured through AUDIT and DUDIT
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in hope from baseline to 4 months post-intervention as measured through BHS
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in social support from baseline to 4 months post-intervention as measured through MSPSS
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family relationship from baseline to 4 months post-intervention as measured through Family Relationship Scale
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family communication from baseline to 4 months post-intervention as measured through the Parent-adolescent Communication Scale
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family communication from baseline to 4 months post-intervention as measured through the Parent-adolescent Sex Communication Scale
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family relationship from baseline to 4 months post-intervention as measured through the Inventory of Parent-peer Attachment
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in parenting from baseline to 4 months post-interventionas measured through the Parental Monitoring Questionnaire
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in parenting from baseline to 4 months post-intervention as measured through the Parenting Scale
Measured: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Caroline Kuo, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432352
- Sponsor's protocol ID
- K01MH096646
- Status last verified
- Jun 2025
- First submitted
- 19 Apr 2015
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuo C, Atujuna M, Mathews C, Stein DJ, Hoare J, Beardslee W, Operario D, Cluver L, K Brown L. Developing family interventions for adolescent HIV prevention in South Africa. AIDS Care. 2016;28 Suppl 1(sup1):106-10. doi: 10.1080/09540121.2016.1146396. Epub 2016 Feb 26.
PubMed 26916841Kuo C, LoVette A, Stein DJ, Cluver LD, Brown LK, Atujuna M, Gladstone TRG, Martin J, Beardslee W. Building resilient families: Developing family interventions for preventing adolescent depression and HIV in low resource settings. Transcult Psychiatry. 2019 Feb;56(1):187-212. doi: 10.1177/1363461518799510. Epub 2018 Oct 5.
PubMed 30289374Kuo C, Mathews C, LoVette A, Harrison A, Orchowski L, Pellowski JA, Atujuna M, Stein DJ, Brown LK. Perpetration of sexual aggression among adolescents in South Africa. J Adolesc. 2019 Apr;72:32-36. doi: 10.1016/j.adolescence.2019.02.002. Epub 2019 Feb 13.
PubMed 30771665Kuo C, LoVette A, Pellowski J, Harrison A, Mathews C, Operario D, Beardslee W, Stein DJ, Brown L. Resilience and psychosocial outcomes among South African adolescents affected by HIV. AIDS. 2019 Jun 1;33 Suppl 1(Suppl 1):S29-S34. doi: 10.1097/QAD.0000000000002177.
PubMed 31397720Kuo C, Mathews C, Giovenco D, Atujuna M, Beardslee W, Hoare J, Stein DJ, Brown LK. Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial. AIDS Educ Prev. 2020 Feb;32(1):67-81. doi: 10.1521/aeap.2020.32.1.67.
PubMed 32202920
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Family Our Future: Family Prevention of HIV Risk and Depression in HIV-endemic South Africa
- ClinicalTrials.gov ID
- NCT02432352
- Acronym / sponsor ID
- K01MH096646
- Conditions
- Sexual Behavior, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- May 2015
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility and acceptability of a family-based preventive intervention designed to reduce sexual risk behaviors and depressive symptoms among South African adolescents and their parents/guardians/caregivers.
Detailed description
The Our Family Our Future Program is a preventive intervention program designed to prevent or reduce adolescent sexual risk behavior and to increase mental health resilience against depression onset among adolescents (13-15 years of age). The intervention takes a family approach and addresses HIV risk and depression in an integrated model. HIV and depression are the leading causes of global burden of disease in low and middle income countries. The intervention is being tested in South Africa, the country confronting the largest HIV epidemic in the world and because preliminary studies with South African families identified poor mental health and sexual risk behavior as priority areas for preventive intervention development and testing.
This study is a randomized pilot design, where 152 adolescents and parents will be randomly assigned to an intervention condition or a standard usual care condition and then offered the experimental intervention as on a wait-list. Families will be recruited and screened for eligibility based on systematic house-to-house recruitment in the community. Eligibility is based on dyadic eligibility and includes age criteria, consistent presence in the household, depressive symptoms that fall below clinically significant threshold criteria, and ability to provide informed consent and assent. Eligible families will be randomized and offered a preventive intervention program in a group format, led by program facilitators in a community setting. The intervention program consists of 3 sessions plus an individualized family meeting. In some modules parents/guardians/caregivers and adolescents will have content delivered together and in some modules parents/guardians/caregivers and adolescents will break out to adult-only or adolescent-only groups.
The overall objective of study is to assess the following study questions:
Question 1: Is this study feasible? Question 2: Is this intervention acceptable to the target population? Question 3: Is there preliminary evidence of hypothesized effects of the intervention, that the intervention will reduce or maintaining symptoms that fall below the clinically significant range for depression and reduce or delay actual or intended sexual risk behavior in adolescents?
The study takes a single blind, randomized pilot trial. The study takes a secondary prevention approach. The investigators collect three sets of data. First, the investigators assess feasibility by examining recruitment rates, attendance, completion, and drop-out rates, and fidelity. Second, the investigators assess acceptability by examining satisfaction data. Third, as a secondary aim, the investigators use pilot data to assess hypothesized intervention effects by examining outcomes at baseline, immediately post-intervention (2-4 weeks after the last intervention session is completed), and at four months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Our Family Our FutureFamilies are randomly allocated to a behavioral intervention arm (called Our Family Our Future) focusing on reducing sexual risk behavior in adolescents and reducing or maintaining symptoms that fall below the clinically significant range for depression. Arms will be allocated using urn randomization. |
| Control | No intervention | –Families are randomly allocated to the control arm (which receives standard usual care, and then offered the intervention after outcome assessments as a wait-list) using urn randomization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- PARENTS/GUARDIANS/CAREGIVERS
- 18+ years
- primary caregiver or the person responsible for childcare in the household on a day to day basis (as identified by the household);
- when more than one primary caregiver exists in the household, one will be chosen at random;
- lives in the household at least 4 days a week
Key exclusion criteria (4 listed)
- PARENTS/GUARDIANS/CAREGIVERS \& Adolescents
- cognitive impairments that would not allow them to provide informed consent or assent;
- if they participated in qualitative phases of the study
- report no or low symptoms or clinically significant thresholds of depression -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Our Family Our FutureThe Our Family Our Future Program is a family preventive intervention that uses resilience and prevention focused strategies to reduce sexual risk behaviors and build mental wellbeing among adolescents. | Behavioural | Intervention |
Primary outcome
Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
as measured through lifetime and past 3 month sexual acts, condom use, HIV and STI status, prior pregnancy
Change or maintenance of depressive symptoms at sub-clinical range from baseline to 4 months post-intervention measured by CES-D and CES-DC
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Self-reported depressive symptoms
Intervention acceptability - satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options
Time frame: acceptability will be assessed during the intervention, an expected average timeframe of 4 weeks
Intervention feasibility measured by attendance, retention for outcome assessments, fidelity
Time frame: cceptability will be assessed during the intervention, an expected average timeframe of 4 weeks
20 secondary outcomes
Change in resilience from baseline to 4 months post-intervention as measured through CD-RISC
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in depression impairment from baseline to 4 months post-intervention as measured through DISP and CPODMV
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in perceived HIV risk susceptibility from baseline to 4 months post-intervention using a ranking derived from a 0-100 and as measured on a likert scale response
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in HIV knowledge from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in HIV stigma from baseline to 4 months post-intervention as measured through the HIV Knowledge Questionnaire
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in norms and attitudes about sex from baseline to 4 months post-intervention as measured on a likert scale response
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in norms and attitudes about condoms from baseline to 4 months post-intervention as measured through the condom attitudes scale and likert response questions
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in sexual behavior self-efficacy from baseline to 4 months post-interventionusing a ranking derived from a 0-100 and as measured on a likert scale response
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in anxiety from baseline to 4 months post-interventionas measured through BAI and RCMAS
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in psychological distress from baseline to 4 months post-intervention as measured through K6 and SDQ
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in trauma symptoms from baseline to 4 months post-intervention as measured through PCL and NSESSS
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in substance use from baseline to 4 months post-intervention as measured through AUDIT and DUDIT
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in hope from baseline to 4 months post-intervention as measured through BHS
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in social support from baseline to 4 months post-intervention as measured through MSPSS
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family relationship from baseline to 4 months post-intervention as measured through Family Relationship Scale
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family communication from baseline to 4 months post-intervention as measured through the Parent-adolescent Communication Scale
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family communication from baseline to 4 months post-intervention as measured through the Parent-adolescent Sex Communication Scale
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in family relationship from baseline to 4 months post-intervention as measured through the Inventory of Parent-peer Attachment
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in parenting from baseline to 4 months post-interventionas measured through the Parental Monitoring Questionnaire
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Change in parenting from baseline to 4 months post-intervention as measured through the Parenting Scale
Time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Results publication: PubMed 26916841Kuo C, Atujuna M, Mathews C, Stein DJ, Hoare J, Beardslee W, Operario D, Cluver L, K Brown L. Developing family interventions for adolescent HIV prevention in South Africa. AIDS Care. 2016;28 Suppl 1(sup1):106-10. doi: 10.1080/09540121.2016.1146396. Epub 2016 Feb 26.
- Results publication: PubMed 30289374Kuo C, LoVette A, Stein DJ, Cluver LD, Brown LK, Atujuna M, Gladstone TRG, Martin J, Beardslee W. Building resilient families: Developing family interventions for preventing adolescent depression and HIV in low resource settings. Transcult Psychiatry. 2019 Feb;56(1):187-212. doi: 10.1177/1363461518799510. Epub 2018 Oct 5.
- Results publication: PubMed 30771665Kuo C, Mathews C, LoVette A, Harrison A, Orchowski L, Pellowski JA, Atujuna M, Stein DJ, Brown LK. Perpetration of sexual aggression among adolescents in South Africa. J Adolesc. 2019 Apr;72:32-36. doi: 10.1016/j.adolescence.2019.02.002. Epub 2019 Feb 13.
- Results publication: PubMed 31397720Kuo C, LoVette A, Pellowski J, Harrison A, Mathews C, Operario D, Beardslee W, Stein DJ, Brown L. Resilience and psychosocial outcomes among South African adolescents affected by HIV. AIDS. 2019 Jun 1;33 Suppl 1(Suppl 1):S29-S34. doi: 10.1097/QAD.0000000000002177.
- Results publication: PubMed 32202920Kuo C, Mathews C, Giovenco D, Atujuna M, Beardslee W, Hoare J, Stein DJ, Brown LK. Acceptability, Feasibility, and Preliminary Efficacy of a Resilience-Oriented Family Intervention to Prevent Adolescent HIV and Depression: A Pilot Randomized Controlled Trial. AIDS Educ Prev. 2020 Feb;32(1):67-81. doi: 10.1521/aeap.2020.32.1.67.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Our Family Our Future in people with Sexual Behavior and Depression, run by Brown University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention (time frame: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432352, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.