Combination Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria

ConditionHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age15-29
SponsorNorthwestern University

About this trial

The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among YMSM and YTW, ages 15-29.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV seropositive

registered as a patient at one of the collaborating key population (KP)-focused community centers

male sex at birth

identify as YMSM or YTW (or report a history of sex with men)

Disqualifiers

Unable to obtain parental permission if 15 years of age and not emancipated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combination Peer navigation and mHealth intervention

    Behavioral

    Peer navigation and SMS text message medication reminders (adapted to YMSM and YTW in community outreach-based delivery approach)

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Combination peer navigation and mHealth InterventionOther 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

HIV viral load suppression

Viral load suppression (\<200 copies/mL) at baseline and 24 weeks

Time frame
Baseline, 24 weeks

Secondary outcomes

1

Retention in HIV care

Two medical visits in the 24-week study period, with a minimum of 60 days between visits

Time frame
Baseline, 24 weeks
2

Medication adherence

Self-reported measure of adherence on visual analogue scale (0-100), with adherence measured as \>or = 90%

Time frame
Baseline, 24 weeks
3

Feasibility of intervention

Phone-related and SMS text-related problems resulting in \<10% message failure, measured by text message platform administrative reports

Time frame
24 weeks
4

Acceptability of intervention

Acceptability report of \>90% agreement based on Client Satisfaction Questionnaire-8 (CSQ-8)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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Northwestern University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator