Johns Hopkins University
Baltimore, Maryland, 21205, United States
Location status: Recruiting
Location contact
Jenny Hope
SUB_INVESTIGATOR
Larissa Jennings Mayo-Wilson, PhD MHS
CONTACT
Nancy Glass, PhD MPH RN
CONTACT
Ninah Bell
SUB_INVESTIGATOR
NCT Number: NCT06096324
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.
Interested in participating?
Request Info18 year–24 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21205, United States
Location status: Recruiting
Jenny Hope
SUB_INVESTIGATOR
Larissa Jennings Mayo-Wilson, PhD MHS
CONTACT
Nancy Glass, PhD MPH RN
CONTACT
Ninah Bell
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
are:
Exclusion criteria
are:
Participants will receive job announcements plus HIV prevention text messages, educational sessions, economic resources, and mentoring.
Participants will receive job announcements only.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Adriana Parker, MPH
CONTACT
Larissa Jennings Mayo-Wilson, PhD MHS
CONTACT
University of North Carolina, Chapel Hill
Other
Acronym: ENSPIRE
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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