iEngage Social Network Intervention for HIV/AIDS

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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the iEngage treatment for HIV/AIDS?

Research shows that using mobile technology, like smartphone apps and text messages, can help people with HIV stay engaged in their care and take their medication regularly. This approach has been linked to better health outcomes, such as keeping the virus under control. ^{1 2 3 4 5}

What makes the iEngage treatment for HIV/AIDS unique?

The iEngage treatment is unique because it combines the use of social network strategies to enhance the effectiveness of HIV interventions, such as promoting self-testing and improving medication adherence, with the drug Dolutegravir (also known as Tivicay). This approach leverages social media and networking sites to support individuals in managing their HIV treatment, which is different from traditional methods that do not typically incorporate these digital tools. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Tiarney Ritchwood, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long term impact of PositiveLinks: Clinic-deployed mobile technology to improve engagement with HIV care. [2020]

2. France pubmed.ncbi.nlm.nih.gov

[Adherence intervention for HIV-infected patients receiving antiretroviral treatment. Implementation and initial assessment]. [2019]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Rapid Review of eHealth Interventions Addressing the Continuum of HIV Care (2007-2017). [2019]

5. England pubmed.ncbi.nlm.nih.gov

Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Social Network Strategies to Distribute HIV Self-testing Kits: A Global Systematic Review and Network Meta-analysis. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A Review of Social Media Technologies Across the Global HIV Care Continuum. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Social Media Interventions to Promote HIV Testing, Linkage, Adherence, and Retention: Systematic Review and Meta-Analysis. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Social Media and HIV: A Systematic Review of Uses of Social Media in HIV Communication. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Lantern Using WhatsApp to Improve Antiretroviral Therapy Adherence. [2023]