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

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.

Study Overview

• Status: Recruiting
• Conditions: Condomless Sex; Utilization, Health Care; Economic Hardship
• Intervention / Treatment: Behavioral: Job announcements; Behavioral: Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larissa Jennings Mayo-Wilson, PhD MHS; Phone Number: 919-445-5099; Email: ljennings.mayowilson@unc.edu
• Study Contact Backup: Name: Adriana Parker, MPH; Phone Number: 919-843-9293; Email: adriana.parker@unc.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Larissa Jennings Mayo-Wilson, PhD MHS; Phone Number: 919-445-5099; Email: ljennings.mayowilson@unc.edu
      • Contact: Nancy Glass, PhD MPH RN; Phone Number: 410-955-4766; Email: nglass1@jhu.edu
      • Sub-Investigator: Jenny Hope
      • Sub-Investigator: Ninah Bell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Job announcements only	Behavioral: Job announcements; Participants will receive job announcements only.
Experimental: Intervention; Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.	Behavioral: Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.; Participants will receive job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean economic stability score of participants in each group in the past six months	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.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Month 3
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	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.	Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants in each group who report one or more paid hours of work in the past six months	The proportion of participants in each group who report one or more paid hours of work in the past six months will be measured using a participant survey.	Month 3, Month 6, Month 12
Mean financial distress score of participants in each group in the past six months	The mean financial distress score of participants in each group in the past six months will be measured using a participant survey. The financial distress scale measures extent of financial distress and ranges from 0 to 10 with higher scores indicating a worse outcome.	Month 3, Month 6, Month 12
Mean total money spent on HIV prevention activities of participants in each group in the past six months	The mean total money spent on HIV prevention activities of participants in each group in the past six months will be measured using a participant survey.	Month 3, Month 6, Month 12
Mean economic self-efficacy score of participants in each group in the past six months	The mean economic self-efficacy score of participants in each group in the past six months will be measured using a participant survey. The economic self-efficacy scale measures extent of economic self-efficacy and ranges from 0 to 16 with higher scores indicating a better outcome.	Month 3, Month 6, Month 12
Proportion of participants in each group who report one or more other sexual risk behaviors associated with HIV acquisition in the past six months	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 will be measured using a participant survey.	Month 3, Month 6, Month 12
Proportion of participants in each group who report one or more other care-seeking behaviors associated with HIV prevention in the past six months	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 will be measured using a participant survey.	Month 3, Month 6, Month 12
Mean condom self-efficacy score of participants in each group in the past six months	The mean condom self-efficacy score of participants in each group in the past six months will be measured using a participant survey. The condom self-efficacy scale measures extent of condom self-efficacy and ranges from 0 to 16 with higher scores indicating a better outcome.	Month 3, Month 6, Month 12
Mean pre-exposure prophylaxis (PrEP) self-efficacy score of participants in each group in the past six months	The mean pre-exposure prophylaxis (PrEP) self-efficacy score of participants in each group in the past six months will be measured using a participant survey. The pre-exposure prophylaxis (PrEP) self-efficacy scale measures extent of PrEP self-efficacy and ranges from 0 to 14 with higher scores indicating a better outcome.	Month 3, Month 6, Month 12
Mean grit score of participants in each group in the past six months	The mean grit score of participants in each group in the past six months will be measured using a participant survey. The grit scale measures extent of grit and ranges from 0 to 18 with higher scores indicating a better outcome.	Month 3, Month 6, Month 12
Mean industriousness score of participants in each group in the last six months	The mean industriousness score of participants in each group in the last six months will be measured using a participant survey. The industriousness scale measures extent of industriousness and ranges from 0 to 26 with higher scores indicating a better outcome.	Month 3, Month 6, Month 12
Mean economic stability score of participants in each group in the past six months	The mean 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.	Month 6, Month 12
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	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.	Month 6, Month 12
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	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.	Month 6, Month 12

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Larissa Jennings Mayo-Wilson, PhD MHS, University of North Carolina, Chapel Hill; Study Director: Adriana Parker, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Treatment Adherence and Compliance; Health Behavior; Sexual Behavior; Financial Stress; Patient Acceptance of Health Care; Unsafe Sex
• Other Study ID Numbers: 23-1034; R01MD016815 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data (IPD) will be shared.
• IPD Sharing Time Frame: The IPD will be posted on a permanent online data repository within 36 months after study completion.
• IPD Sharing Access Criteria: There are no access criteria.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No