AzTrials
AzTrials

Economic HardshipENSPIRENCT06096324

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

A study testing Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring. and Job announcements in people with Economic Hardship and Condomless Sex, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
What is being tested?
Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring. and Job announcements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
19 Sep 2023to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Larissa Jennings Mayo-Wilson, PhD MHS contact

919-445-5099

ljennings.mayowilson@unc.edu

Adriana Parker, MPH contact

919-843-9293

adriana.parker@unc.edu

United States1 site, 1 recruiting
  • Johns Hopkins University

    Baltimore, Maryland, 21205

    Nancy Glass, PhD MPH RN, 410-955-4766, nglass1@jhu.edu

    Larissa Jennings Mayo-Wilson, PhD MHS, 919-445-5099, ljennings.mayowilson@unc.edu

    Recruiting

Other trials in United States

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. 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.

Read the 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.

Being tested
Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring., Job announcements
Keywords
HIV
Medical subject headings
Financial Stress, Unsafe Sex, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Job announcementsBehavioural

    Participants will receive job announcements only.

Study groups in NCT06096324
Study groupRoleWhat they receive
InterventionExperimentalJob announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.
Receives: Behavioral: Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.
ControlOtherJob announcements only
Receives: Behavioral: Job announcements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 3

Secondary outcomes (2)
  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

    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.

    Measured: Month 3

  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

    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.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start19 Sep 2023
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096324
Sponsor's protocol ID
23-1034
Other IDs
R01MD016815
Acronym
ENSPIRE
Status last verified
Mar 2026
First submitted
9 Oct 2023
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data (IPD) will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring. and Job announcements in people with Economic Hardship and Condomless Sex, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Larissa Jennings Mayo-Wilson, PhD MHS (919-445-5099, ljennings.mayowilson@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean economic stability score of participants in each group in the past six months (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in