Clinical trial NCT06096324: Intervention for Sexual and Biomedical HIV Prevention in Vulnerable U.S. Young Adults
Official title: Microenterprise and Behavioral Economics Intervention for Sexual and Biomedical HIV Prevention in Vulnerable U.S. Young Adults (EMERGE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Economic Hardship
Condomless Sex
Utilization, Health Care
Keywords: HIV
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-23
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria are:

* Aged 18-24
* African-American
* Economically-vulnerable in past 12 months
* Sexually active in past 12 months
* Living in Baltimore
* Has access to mobile phone with text messaging

Exclusion criteria are:

* Aged 17 or younger
* Older than 24 years
* Unwilling to provide consent for study participation

Primary outcomes:
measure: Mean economic stability score of participants in each group in the past six months
timeFrame: Month 3
Secondary outcomes:
measure: 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
timeFrame: Month 3
measure: 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
timeFrame: Month 3
Other outcomes:
measure: Proportion of participants in each group who report one or more paid hours of work in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean financial distress score of participants in each group in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean total money spent on HIV prevention activities of participants in each group in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean economic self-efficacy score of participants in each group in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Proportion of participants in each group who report one or more other sexual risk behaviors associated with HIV acquisition in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Proportion of participants in each group who report one or more other care-seeking behaviors associated with HIV prevention in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean condom self-efficacy score of participants in each group in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean pre-exposure prophylaxis (PrEP) self-efficacy score of participants in each group in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean grit score of participants in each group in the past six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean industriousness score of participants in each group in the last six months
timeFrame: Month 3, Month 6, Month 12, Month 18, Month 24
measure: Mean economic stability score of participants in each group in the past six months
timeFrame: Month 6, Month 12, Month 18, Month 24
measure: 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
timeFrame: Month 6, Month 12, Month 18, Month 24
measure: 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
timeFrame: Month 6, Month 12, Month 18, Month 24
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Larissa Jennings Mayo-Wilson, PhD MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Adriana Parker, MPH
role: STUDY_DIRECTOR
References: