HIV/AIDSNCT04077047
Adolescents Living With HIV (ALWH): Social Networks, Adherence and Retention
A study testing iEngage in people with HIV/AIDS, run by Wake Forest University Health Sciences at 2 sites in 2 countries.
Trial summary
human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- iEngage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2022to 31 Jul 2025
- Phase
- Interventional
- 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 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- reside in study area
- able to provide consent or assent
- agreeable to allowing the research team to have access to their clinic data to assess retention in human immunodeficiency virus- (HIV) care and antiretroviral therapy (ART) adherence
- each Adolescents living with HIV (ALWH) must recruit at least one social network member to participate in the intervention with them
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: Understanding and Developing a Network-based Social Support Intervention to Improve Retention in Human Immunodeficiency Virus (HIV) Care and Antiretroviral Therapy Adherence for Adolescents Living With HIV
human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Despite having the world's largest population of Adolescents living with HIV (ALWH) (15-24 years, n=870,000), only 14% of South African ALWH are on ART, 12% are retained in HIV care 1-2 years after ART initiation, and 10% are virally suppressed. During treatment interruption, the effects of ART quickly reverse, increasing transmission risk, treatment resistance, and potentially fatal complications. Unless their treatment retention and adherence improves, ALWH will continue to transmit the virus to their sexual partners and die prematurely.
While social support is often viewed as a bridge that joins ALWH to key resources within their environments, little is known about which types of social support are most impactful and from whom within their network, particularly among ALWH in endemic countries. Moreover, many South African ALWH lack social support from key social network members due to lack of HIV status disclosure, increasing their risk for poorer HIV-related outcomes when compare to their disclosed peers. Social network interventions (i.e., those that leverage the resources within one's network to improve behaviors and outcomes) that meet the needs of both ALWH who are disclosed and non-disclosed are needed, but lacking. Such inventions have the potential to facilitate appraisal support, during which ALWH receive targeted assistance with identifying appropriate and trustworthy people in their lives. More broadly, there exists a lack empirically supported interventions aimed at improving retention in HIV care and ART adherence for ALWH in low-middle income countries.
This proposal follows the multiphase optimization strategy (MOST), a comprehensive framework for optimizing and evaluating multicomponent behavioral interventions.
Read the detailed description
This K08 focuses on the preparation phase, which consists of compiling information from various sources, including behavioral theory, scientific literature, secondary analyses of existing data, and formative research to inform a theoretical model. This model guides intervention-related decisions, such as the selection of intervention components. Piloting of intervention components and the identification and operationalization of an optimization criterion also occur in this phase. The investigators will first use social network analyses to elucidate network characteristics that influence ALWHs' retention and adherence (Aim 1), then use participatory methods to inform intervention development (Aim 2), and lastly assess intervention acceptability, feasibility, safety and evidence of efficacy (Aim 3). Aim 3 is the clinical trial component and described in detail below. Aim 1 will determine how ALWHs' social networks influence their retention in HIV care and ART adherence and Aim 2 will then focus on the development of a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence informed by Aim 1 and other relevant information.
The goal of aim 3 is to assess intervention acceptability, feasibility, safety and evidence of efficacy through open piloting. The investigators will assess intervention acceptability, feasibility, safety, and evidence of efficacy using an iterative process enabling feedback and continuing quality improvement over the course of implementation. This approach involves the piloting of the network intervention developed in Aim 2. The rationale is that the best interventions for ALWH will consider their unique needs and include tailored components. The outcome of this Aim will be a feasible and acceptable social network intervention that will be tested in an adaptive intervention using future grant funding. The hypothesis for aim 3 is that the intervention will be acceptable, feasible, and safe, with trends towards improved ALWH retention in HIV care and ART adherence.
- Conditions
- HIV/AIDS
- Being tested
- iEngage
- Keywords
- Adolescents
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iEngageBehavioural
Also called network-based, social support intervention
The intervention is a network-based, social support intervention to improve Adolescents living with HIV (ALWH) retention in HIV care and antiretroviral therapy (ART) adherence
| Study group | Role | What they receive |
|---|---|---|
| iEngage | Experimental | The intervention is a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence. The specific intervention will be developed during Aim 2 of the study and uses qualitative findings, along with data from Aim 1, to develop an interventions that integrates participant feedback and borrows components from two existing interventions Receives: Behavioral: iEngage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: exit interviews
Measured using exit interviews
Measured: 12 month follow up
Acceptability: exit interviews
Measured using exit interviews
Measured: 12 month follow up
Secondary outcomes (21)
Change in HIV stigma & discrimination
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in HIV knowledge
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in autonomy
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in sense of community
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in basic psychological needs
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in social support
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in trust
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in relationship equity
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in agency
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in future orientation
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in mental health
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in healthcare access
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in physical health
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in housing stability
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in economic support
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in income
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in food security
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in food transportation
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in viral load
Gathered from existing medical records
Measured: baseline, 6 month, and 12 month follow up
Change in ART adherence
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Change in retention in HIV care
may include de novo questionnaire, interview
Measured: baseline, 6 month, and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Sep 2022
- Primary completion17 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Tiarney Ritchwood, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077047
- Sponsor's protocol ID
- IRB00099951
- Other IDs
- 5K08MH118965-02
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Developing a Network-based Social Support Intervention to Improve Retention in Human Immunodeficiency Virus (HIV) Care and Antiretroviral Therapy Adherence for Adolescents Living With HIV
- ClinicalTrials.gov ID
- NCT04077047
- Acronym / sponsor ID
- IRB00099951
- Conditions
- HIV/AIDS
- Keywords
- Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Sep 2019 (actual)
- 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.
human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Despite having the world's largest population of Adolescents living with HIV (ALWH) (15-24 years, n=870,000), only 14% of South African ALWH are on ART, 12% are retained in HIV care 1-2 years after ART initiation, and 10% are virally suppressed. During treatment interruption, the effects of ART quickly reverse, increasing transmission risk, treatment resistance, and potentially fatal complications. Unless their treatment retention and adherence improves, ALWH will continue to transmit the virus to their sexual partners and die prematurely.
While social support is often viewed as a bridge that joins ALWH to key resources within their environments, little is known about which types of social support are most impactful and from whom within their network, particularly among ALWH in endemic countries. Moreover, many South African ALWH lack social support from key social network members due to lack of HIV status disclosure, increasing their risk for poorer HIV-related outcomes when compare to their disclosed peers. Social network interventions (i.e., those that leverage the resources within one's network to improve behaviors and outcomes) that meet the needs of both ALWH who are disclosed and non-disclosed are needed, but lacking. Such inventions have the potential to facilitate appraisal support, during which ALWH receive targeted assistance with identifying appropriate and trustworthy people in their lives. More broadly, there exists a lack empirically supported interventions aimed at improving retention in HIV care and ART adherence for ALWH in low-middle income countries.
This proposal follows the multiphase optimization strategy (MOST), a comprehensive framework for optimizing and evaluating multicomponent behavioral interventions.
Detailed description
This K08 focuses on the preparation phase, which consists of compiling information from various sources, including behavioral theory, scientific literature, secondary analyses of existing data, and formative research to inform a theoretical model. This model guides intervention-related decisions, such as the selection of intervention components. Piloting of intervention components and the identification and operationalization of an optimization criterion also occur in this phase. The investigators will first use social network analyses to elucidate network characteristics that influence ALWHs' retention and adherence (Aim 1), then use participatory methods to inform intervention development (Aim 2), and lastly assess intervention acceptability, feasibility, safety and evidence of efficacy (Aim 3). Aim 3 is the clinical trial component and described in detail below. Aim 1 will determine how ALWHs' social networks influence their retention in HIV care and ART adherence and Aim 2 will then focus on the development of a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence informed by Aim 1 and other relevant information.
The goal of aim 3 is to assess intervention acceptability, feasibility, safety and evidence of efficacy through open piloting. The investigators will assess intervention acceptability, feasibility, safety, and evidence of efficacy using an iterative process enabling feedback and continuing quality improvement over the course of implementation. This approach involves the piloting of the network intervention developed in Aim 2. The rationale is that the best interventions for ALWH will consider their unique needs and include tailored components. The outcome of this Aim will be a feasible and acceptable social network intervention that will be tested in an adaptive intervention using future grant funding. The hypothesis for aim 3 is that the intervention will be acceptable, feasible, and safe, with trends towards improved ALWH retention in HIV care and ART adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iEngage | Experimental | Behavioral: iEngageThe intervention is a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence. The specific intervention will be developed during Aim 2 of the study and uses qualitative findings, along with data from Aim 1, to develop an interventions that integrates participant feedback and borrows components from two existing interventions |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- reside in study area
- able to provide consent or assent
- agreeable to allowing the research team to have access to their clinic data to assess retention in human immunodeficiency virus- (HIV) care and antiretroviral therapy (ART) adherence
- each Adolescents living with HIV (ALWH) must recruit at least one social network member to participate in the intervention with them
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| iEngageAlso: network-based, social support interventionThe intervention is a network-based, social support intervention to improve Adolescents living with HIV (ALWH) retention in HIV care and antiretroviral therapy (ART) adherence | Behavioural | iEngage |
Primary outcome
Feasibility: exit interviews
Time frame: 12 month follow up
Measured using exit interviews
Acceptability: exit interviews
Time frame: 12 month follow up
Measured using exit interviews
21 secondary outcomes
Change in HIV stigma & discrimination
Time frame: baseline, 6 month, and 12 month follow up
Change in HIV knowledge
Time frame: baseline, 6 month, and 12 month follow up
Change in autonomy
Time frame: baseline, 6 month, and 12 month follow up
Change in sense of community
Time frame: baseline, 6 month, and 12 month follow up
Change in basic psychological needs
Time frame: baseline, 6 month, and 12 month follow up
Change in social support
Time frame: baseline, 6 month, and 12 month follow up
Change in trust
Time frame: baseline, 6 month, and 12 month follow up
Change in relationship equity
Time frame: baseline, 6 month, and 12 month follow up
Change in agency
Time frame: baseline, 6 month, and 12 month follow up
Change in future orientation
Time frame: baseline, 6 month, and 12 month follow up
Change in mental health
Time frame: baseline, 6 month, and 12 month follow up
Change in healthcare access
Time frame: baseline, 6 month, and 12 month follow up
Change in physical health
Time frame: baseline, 6 month, and 12 month follow up
Change in housing stability
Time frame: baseline, 6 month, and 12 month follow up
Change in economic support
Time frame: baseline, 6 month, and 12 month follow up
Change in income
Time frame: baseline, 6 month, and 12 month follow up
Change in food security
Time frame: baseline, 6 month, and 12 month follow up
Change in food transportation
Time frame: baseline, 6 month, and 12 month follow up
Change in viral load
Time frame: baseline, 6 month, and 12 month follow up
Change in ART adherence
Time frame: baseline, 6 month, and 12 month follow up
Change in retention in HIV care
Time frame: baseline, 6 month, and 12 month follow up
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Tiarney Ritchwood, PhD principal investigator
Wake Forest University Health Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iEngage in people with HIV/AIDS, run by Wake Forest University Health Sciences at 2 sites in 2 countries.
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 4 inclusion and 1 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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.
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?
Feasibility: exit interviews (time frame: 12 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.