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

Utilization, Health Care Clinical Trial

— EMERGE  

Official title:

Microenterprise and Behavioral Economics Intervention for Sexual and Biomedical HIV Prevention in Vulnerable U.S. Young Adults (EMERGE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096324
• Other study ID #: 23-1034
• Secondary ID: R01MD016815
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Larissa Jennings Mayo-Wilson, PhD MHS
• Phone: 919-445-5099
• Email: ljennings.mayowilson[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Condomless Sex
• Financial Stress
• Utilization, Health Care

Intervention

Behavioral:
• Job announcements plus educational sessions, mentoring, a micro-grant, and behavioral economic text messages
Participants will receive job announcements plus educational sessions, mentoring, a micro-grant, and behavioral economic text messages.
• Job announcements
Participants will receive job announcements only.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Other	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, Month 18, Month 24
Primary	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	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
Secondary	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