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NCT Number: NCT06096324

Education and Employment Support for HIV Prevention in Young Adults (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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Jenny Hope

SUB_INVESTIGATOR

Larissa Jennings Mayo-Wilson, PhD MHS

CONTACT

[email protected]

919-445-5099

Nancy Glass, PhD MPH RN

CONTACT

[email protected]

410-955-4766

Ninah Bell

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Participants will receive job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.

Job announcements

Behavioral

Participants will receive job announcements only.

Primary outcomes

  1. Mean economic stability score of participants in each group in the past six months

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

Other outcomes

  1. Proportion of participants in each group who report one or more paid hours of work in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  2. Mean financial distress score of participants in each group in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  3. Mean total money spent on HIV prevention activities of participants in each group in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  4. Mean economic self-efficacy score of participants in each group in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  5. Proportion of participants in each group who report one or more other sexual risk behaviors associated with HIV acquisition in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  6. Proportion of participants in each group who report one or more other care-seeking behaviors associated with HIV prevention in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  7. Mean condom self-efficacy score of participants in each group in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  8. Mean pre-exposure prophylaxis (PrEP) self-efficacy score of participants in each group in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  9. Mean grit score of participants in each group in the past six months

    Time frame: Month 3, Month 6, Month 12

    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.

  10. Mean industriousness score of participants in each group in the last six months

    Time frame: Month 3, Month 6, Month 12

    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.

  11. Mean economic stability score of participants in each group in the past six months

    Time frame: Month 6, Month 12

    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.

  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

    Time frame: Month 6, Month 12

    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.

  13. 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

    Time frame: Month 6, Month 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Parker, MPH

CONTACT

[email protected]

919-843-9293

Larissa Jennings Mayo-Wilson, PhD MHS

CONTACT

[email protected]

919-445-5099

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: ENSPIRE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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