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Hybrid Type I Effectiveness-Implementation Trial of a Social Network Support Intervention

ConditionHIV Seropositivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of Chicago

About this trial

The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18-49 years old, inclusive

Speak English

Own a cell phone not shared with anyone else

Have missed at least one HIV care scheduled visit or have not been virally suppressed in the past 24 months.

Disqualifiers

If a participant fails to meet all inclusion criteria

Index agrees to engage the Support Confidant

Age 18 years or older

Speaks English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Social Network Support Intervention

    Behavioral

    The Social Network Support Intervention is an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV. The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference.

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Social Network Support Intervention ConditionExperimental treatment 1 intervention
Group B: Treatment as Usual ConditionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Missed Visit Proportion

We count visits as scheduled (non-acute) visits to an antiretroviral prescribing provider. Missed Visit Proportion (MVP) is calculated as the proportion of total scheduled visits that are missed during the follow-up period. To permit longitudinal analyses, we shall also split the two-year follow-up period into eight three-month quarters and record, for each participant, whether he completed or missed his scheduled appointment during that quarter. Appointment and visit history to calculate MVP will be collected from each clinic's electronic medical record data.

Time frame
18 months
2

Viral Suppression

Viral load (suppressed or not) will be measured in RNA copies/mL, with ≤200 copies/mL defined as viral suppression.

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Chicago

Lead sponsor

Tulane University

Collaborator

University of Alabama at Birmingham

Collaborator

Birmingham AIDS Outreach

Collaborator

Chicago Center for HIV Elimination

Collaborator

Howard Brown Health

Collaborator

Thrive Alabama

Collaborator

Source ClinicalTrials.gov
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