iEngage Social Network Intervention for HIV/AIDS

No longer recruiting at 3 trial locations

Overseen By Tiarney Ritchwood, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Antiretrovirals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adolescents living with HIV in South Africa stay on their medications and improve their health through a social support system. Researchers seek to determine which types of social support are most effective and from whom. Participants and their chosen social network members will join a new program, tentatively called iEngage, designed to enhance medication adherence and retention in care. Adolescents living with HIV who can bring at least one supportive person from their life may be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in social support for better health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social support and improving adherence to HIV treatment, so it's likely you can continue your current medications.

What prior data suggests that this social network intervention is safe for adolescents living with HIV?

Research has shown that social network programs, like iEngage, can safely and effectively help people with HIV improve their health. Studies on similar programs have found that they help individuals remain engaged in their HIV care and better control the virus, reducing its activity in their bodies.

One study with 127 participants demonstrated that a similar program significantly improved their involvement in care over two years. This suggests that these types of social support programs are generally well-received, with no major safety issues reported.

While specific data on iEngage is still being gathered, the positive results from similar programs suggest it could be a safe way to help adolescents with HIV adhere to their treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iEngage Social Network Intervention because it offers a fresh approach to supporting people living with HIV/AIDS. Unlike standard treatments, which focus mainly on medication adherence through medical appointments and direct healthcare provider support, iEngage leverages social networks to enhance patient retention in care and adherence to antiretroviral therapy (ART). By integrating participant feedback and elements from proven interventions, iEngage aims to create a supportive community environment that complements medical treatment. This innovative method could lead to better long-term health outcomes by fostering a sense of connection and accountability among patients.

What evidence suggests that this social network intervention is effective for improving HIV care retention and ART adherence in adolescents?

Research has shown that social networks can improve the health of teenagers living with HIV. This trial will evaluate the iEngage intervention, a network-based social support strategy designed to enhance retention in HIV care and ART adherence among adolescents with HIV. Studies have found that mobile technology, such as smartphone apps and text messages, aids these teens in following their HIV treatment plans more effectively. By leveraging social networks, these tools provide support and advice, helping teens remain in care and adhere to their medication. Additionally, a strong support network can reduce stigma and promote healthy behaviors. Overall, these strategies appear promising in helping teens with HIV maintain their treatment and improve their health. ^{1 3 4 6 7}

Who Is on the Research Team?

Tiarney Ritchwood, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adolescents living with HIV in South Africa who are willing to let researchers access their clinic data, live in the study area, and can consent or bring a social network member to join the intervention.

Inclusion Criteria

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 HIV care and ART adherence

Exclusion Criteria

N/A

Timeline for a Trial Participant

Preparation

Compiling information from various sources to inform a theoretical model and guide intervention-related decisions.

Not specified

Intervention Development

Development of a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence.

Not specified

Open Piloting

Assess intervention acceptability, feasibility, safety, and evidence of efficacy using an iterative process.

12 months

Baseline, 6 month, and 12 month follow-up visits

Follow-up

Participants are monitored for changes in social support, mental health, healthcare access, and other outcomes.

12 months

Baseline, 6 month, and 12 month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• iEngage (tentative title)

Trial Overview

The 'iEngage' intervention is being tested to see if it improves retention in HIV care and antiretroviral therapy adherence among adolescents by leveraging social support within their networks.

How Is the Trial Designed?

Group I: iEngage Experimental Treatment 1 Intervention

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

iEngage (tentative title) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tivicay for:

• HIV infection in adults and children

Approved in European Union as Tivicay for:

• HIV infection in adults, adolescents, and children above six years of age

Approved in Canada as Tivicay for:

• HIV infection in adults and children

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Social network strategies significantly enhance the uptake of HIV self-testing (HIVST), with peer distribution showing the highest effectiveness, leading to a 79% probability of increased testing compared to standard facility-based methods.

Both peer and partner distribution methods not only improved HIV testing rates but also increased the likelihood of detecting HIV reactivity, while linkage to antiretroviral therapy (ART) remained similar to traditional testing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Network Strategies to Distribute HIV Self-testing Kits: A Global Systematic Review and Network Meta-analysis. Hu, S., Jing, F., Fan, C., et al.[2023]

A systematic review of 35 studies found that social media, particularly text messaging, is widely used for HIV prevention and treatment communication, allowing diverse users to share information and support each other.

Anonymity is crucial for users discussing HIV on social media due to stigma, highlighting the need for careful consideration of privacy in future research and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Media and HIV: A Systematic Review of Uses of Social Media in HIV Communication. Taggart, T., Grewe, ME., Conserve, DF., et al.[2022]

The InfoPlus Adherence intervention, which combines electronic alerts and brief counseling, showed a significant increase in ART adherence (≥90% of days covered) among patients in Haiti, with a relative risk of 4.00, indicating a strong positive effect on adherence compared to historical controls.

While the intervention did not show a statistically significant improvement in HIV viral suppression rates (80.0% vs. 76.8% for controls), it demonstrated a favorable trend, suggesting potential benefits that warrant further investigation into its efficacy and implementation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An EMR-Based Alert with Brief Provider-Led ART Adherence Counseling: Promising Results of the InfoPlus Adherence Pilot Study Among Haitian Adults with HIV Initiating ART. Puttkammer, N., Simoni, JM., Sandifer, T., et al.[2021]

The PositiveLinks (PL) smartphone platform significantly improved engagement in care and HIV viral suppression among 127 participants over a 24-month period, with notable improvements seen as early as 6 months.

Patients who used PL more frequently were over twice as likely to achieve viral suppression and 1.5 times more likely to engage in care compared to those with lower usage, highlighting the effectiveness of mobile technology in managing HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. Canan, CE., Waselewski, ME., Waldman, ALD., et al.[2020]

Social media interventions have been shown to significantly increase HIV testing uptake among men who have sex with men (MSM), with a relative risk of 1.50 based on data from 1283 participants.

Participatory social media interventions, where users engage actively, resulted in even higher testing rates, with a relative risk of 1.64 in studies involving 1023 participants, highlighting the effectiveness of interactive community-building in promoting health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis. Cao, B., Gupta, S., Wang, J., et al.[2023]

A review of 45 studies on eHealth interventions for HIV care found that about 75% demonstrated effectiveness in improving Continuum of HIV Care (CoC) outcomes, particularly in medication adherence.

Mobile texting was the most commonly used technology, highlighting its role in enhancing patient engagement and adherence to treatment, although there are still gaps in the development of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Rapid Review of eHealth Interventions Addressing the Continuum of HIV Care (2007-2017). Henny, KD., Wilkes, AL., McDonald, CM., et al.[2019]

The educational and counseling intervention improved adherence to antiretroviral therapy (ARV) in 84% of treatment-naive patients and 93% of patients receiving reinforcement, indicating high effectiveness in preventing virological failure.

The intervention was less effective for patients from outside Europe, suggesting that cultural or social factors may influence adherence to ARV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adherence intervention for HIV-infected patients receiving antiretroviral treatment. Implementation and initial assessment]. Berki-Benhaddad, Z., Ecobichon, JL., Mentré, F., et al.[2019]

A systematic review of 44 studies over the past decade found that social media and social networking sites are increasingly being used to improve outreach, surveillance, and prevention/treatment efforts for HIV, with a significant focus on engaging communities through platforms like Facebook.

Most studies targeted at-risk populations, particularly men who have sex with men (54.5%) and youth (29.5%), but there is a notable lack of research specifically addressing the needs of HIV-positive individuals (11.4%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Social Media Technologies Across the Global HIV Care Continuum. Garett, R., Smith, J., Young, SD.[2022]

The Lantern program, which uses WhatsApp to support adherence to HIV medications, was found to be safe, practical, and effective in motivating participants to take their antiretroviral therapy on time during an 8-week pilot study with 30 participants.

Participants reported feeling supported and continued to use medication reminder alarms, indicating that the program is feasible and acceptable for improving adherence to HIV treatment in Indonesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Lantern Using WhatsApp to Improve Antiretroviral Therapy Adherence. Ismail, R., Yona, S., Nurachmah, E., et al.[2023]

The study found that both SMS reminders and SMS combined with peer navigation significantly improved the rate of linkage to HIV care compared to standard care, with participants using SMS linking at 1.28 times and those using SMS+PN linking at 1.60 times the rate of standard care participants.

Additionally, the SMS+PN approach notably reduced the time to start antiretroviral therapy (ART) among non-pregnant women and men, indicating its potential effectiveness in enhancing HIV treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa. Lippman, SA., de Kadt, J., Ratlhagana, MJ., et al.[2023]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714417307747

Rationale and design of iENGAGE intervention trial

R.N. Robbins et al. Optimizing ART adherence: update for HIV treatment and prevention. Curr. HIV/AIDS Rep. (2014).

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8075078/

Effects of an intervention on internalized HIV-related stigma ...

“Straight Talk”: The effectiveness of a psychoeducational group intervention for heterosexuals with HIV/AIDS. Research on Social Work Practice 1997; 7:149–164.

3.

withpower.com

withpower.com/trial/phase-hiv-infections-8-2022-436f6

iEngage Social Network Intervention for HIV/AIDS

What data supports the effectiveness of the iEngage treatment for HIV/AIDS? Research shows that using mobile technology, like smartphone apps and text ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04077047

Adolescents Living With HIV (ALWH): Social Networks ...

Study Overview. Brief Summary. human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death ...

5.

thelancet.com

thelancet.com/journals/langlo/article/PIIS2214-109X(24)00539-4/fulltext

The effect of a social network-based intervention to ...

Network-central promoters in control clusters were trained on basic HIV and AIDS literacy and how to promote referrals to local clinics to get ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29526609/

Rationale and design of iENGAGE intervention trial - PubMed

Assessing effects of behavioral intervention on treatment outcomes among patients initiating HIV care: Rationale and design of iENGAGE intervention trial.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7497372/

Social Network Interventions for HIV Transmission Elimination

Network interventions for HIV prevention represent a potential area for growth in a globalizing world, where persons are more easily connected to one another.