Intervention for Sexual and Biomedical HIV Prevention in Vulnerable U.S. Young Adults

Not Applicable

Recruiting

• Conditions: Condomless Sex; Utilization, Health Care; Economic Hardship
• Interventions: Behavioral: Job announcements plus educational sessions, mentoring, a micro-grant, and behavioral economic text messages; Behavioral: Job announcements

• Registration Number: NCT06096324
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The study team will conduct a two-group study to examine the efficacy of implementing an enhanced microenterprise intervention to improve economic stability and HIV preventive behaviors. The team will enroll approximately 780 young adults. Participants will be randomly assigned to one of two groups. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and employment educational sessions, mentorship, a micro-grant, and HIV behavioral economics text messages.

Detailed Description

The study team will conduct a two-group study to examine the efficacy of implementing an enhanced microenterprise intervention to improve economic stability and HIV preventive behaviors. The team will enroll approximately 780 young adults, aged 18 to 24, who are African-American, economically-vulnerable, sexually active, living in Baltimore, and have access to a mobile phone with text messaging. Participants will be recruited using respondent-driven sampling and be randomly assigned to one of two groups by cluster, equal to a seed and recruits. The first group ("control") will receive text messages with information on job openings. The second group ("intervention") will receive text messages with information on job openings plus HIV prevention and employment educational sessions, mentorship, a micro-grant, and HIV behavioral economics text messages. Both groups will receive the assigned intervention for 12 weeks, equal to approximately 3 months. Data will be collected using participant surveys for two years at pre-intervention (Time 0), immediately post-intervention (Time 1, primary endpoint), and 6-, 12-, 18-, and 24-months post-intervention (Time 2 to Time 5, longitudinal endpoints). Participants will undergo a baseline interview at the time of enrollment (Time 0) and be randomized to a group. Each group will receive the assigned activities for 12 weeks, at which point a follow-up interview will be conducted (Time 1, primary endpoint).

The study team will collect efficacy data pertaining to the following outcomes at T1 (Aim 1): (i) the mean economic stability score of participants in each group in the past six months (=primary outcome); (ii), the proportion of participants in each group who report one or more vaginal or anal sex acts without using a condom in the past six months (=secondary outcome); and (iii) the proportion of participants in each group who report PrEP continuum progressive movement of one or more stages in the past six months (=secondary outcome). All outcomes data will be collected using participant surveys.

The study team will also collect data on other pre-specified measures from T1 to T5 to characterize the primary and secondary aims (Aim 1), to assess differences in the efficacy of the intervention by gender identity and peer support (Aim 2), and to explore potential mediating factors over time (Aim 3). These other pre-specified measures include: (i) the proportion of participants in each group who report one or more paid hours of work in the past six months; (ii) the mean financial distress score of participants in each group in the past six months; (iii) the mean total money spent on HIV prevention activities of participants in each group in the past six months; (iv) the mean economic self-efficacy score of participants in each group in the past six months; (v) the proportion of participants in each group who report one or more other sexual risk behaviors associated with HIV acquisition in the past six months; (vi) the proportion of participants in each group who report one or more other care-seeking behaviors associated with HIV prevention in the past six months; (vii) the mean condom self-efficacy score of participants in each group in the past six months; (viii) the mean PrEP self-efficacy score of participants in each group in the past six months; (ix) the mean grit score of participants in each group in the past six months; and (x) the mean industriousness score of participants in each group in the past six months. All other pre-specified data will also be collected using participant surveys.

Study Timeline

• Study Start: 2023-09-19
• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Job announcements plus educational sessions, mentoring, a micro-grant, and behavioral economic text messages	Job announcements plus educational sessions, mentoring, a micro-grant, and behavioral economic text messages.
Control	Job announcements	Job announcements only

Primary Outcome Measures

Name	Time	Method
Mean economic stability score of participants in each group in the past six months	Month 3	The economic stability score of participants in each group in the past six months will be measured using a participant survey. The economic stability scale measures extent of economic stability and ranges from 0 to 64 with higher scores indicating a better outcome.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants in each group who report one or more vaginal or anal sex acts without using a condom in the past six months	Month 3	The proportion of participants in each group who report one or more vaginal or anal sex acts without using a condom in the past six months will be measured using a participant survey.
Proportion of participants in each group who report pre-exposure prophylaxis (PrEP) continuum progressive movement of one or more stages in the past six months	Month 3	The proportion of participants in each group who report pre-exposure prophylaxis (PrEP) continuum progressive movement of one or more stages in the past six months will be measured using a participant survey. Participants will be assigned to one of nine stages based on their survey responses.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States