Education and Employment Support for HIV Prevention in Young Adults (ENSPIRE)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Economic Hardship; Utilization, Health Care; Condomless Sex

Treatments: Behavioral: Job announcements; Behavioral: Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06096324

R01MD016815 (U.S. NIH Grant/Contract)

23-1034

Details and patient eligibility

About

The study team will conduct a two-group study to examine the efficacy of implementing a combination intervention to improve economic stability and HIV preventive behaviors. The team will enroll approximately 500 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 text messages, educational sessions on employment, income generation, and HIV prevention, economic resources, and mentoring.

Full description

The study team will conduct a two-group study to examine the efficacy of implementing a combination intervention to improve economic stability and HIV preventive behaviors. The team will enroll approximately 500 young adults, aged 18 to 24, who are 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 text messages, educational sessions on employment, income generation, and HIV prevention, economic resources, and mentoring. Both groups will receive the assigned intervention for 12 weeks, equal to approximately 3 months. Data will be collected using participant surveys for one year at pre-intervention (Time 0), immediately post-intervention (Time 1, primary endpoint), and 6- and 12-months post-intervention (Time 2 to Time 3, 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 T3 to characterize the primary and secondary aims (Aim 1), to assess differences in the efficacy of the intervention by sex 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are:

• Aged 18-24
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Intervention

Experimental group

Description:

Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

Treatment:

Behavioral: Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

Control

Other group

Description:

Job announcements only

Treatment:

Behavioral: Job announcements