NCT06096324

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Sep 2023Mar 2028

Study Start

First participant enrolled

September 19, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

October 9, 2023

Last Update Submit

March 3, 2026

Conditions

Economic HardshipCondomless SexUtilization, Health Care

Keywords

HIV

Outcome Measures

Primary Outcomes (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.

    Month 3

Secondary Outcomes (2)

  • 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

    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

    Month 3

Other Outcomes (13)

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

    Month 3, Month 6, Month 12

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

    Month 3, Month 6, Month 12

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

    Month 3, Month 6, Month 12

  • +10 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Control

OTHER

Job announcements only

Behavioral: Job announcements

Interventions

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.

Intervention
Job announcementsBEHAVIORAL

Participants will receive job announcements only.

Control

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Financial StressUnsafe SexPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorSexual BehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Larissa Jennings Mayo-Wilson, PhD MHS

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Adriana Parker, MPH

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR

Central Study Contacts

Larissa Jennings Mayo-Wilson, PhD MHS

CONTACT

919-445-5099ljennings.mayowilson@unc.edu

Adriana Parker, MPH

CONTACT

919-843-9293adriana.parker@unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 23, 2023

Study Start

September 19, 2023

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified individual patient data (IPD) will be shared.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The IPD will be posted on a permanent online data repository within 36 months after study completion.
Access Criteria
There are no access criteria.

Locations

US(1)