Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MD016815 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring. |
|
| Control | Other | Job announcements only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion criteria are:
Exclusion criteria are:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
De-identified individual patient data (IPD) will be shared.
The IPD will be posted on a permanent online data repository within 36 months after study completion.
There are no access criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Job announcements | Behavioral | Participants will receive job announcements only. |
|
| 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 |
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 |
| ID | Term |
|---|---|
| D000086522 | Financial Stress |
| D047568 | Unsafe Sex |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided