Trial Outcomes & Findings for Mobile Enhanced Prevention Support for People Leaving Jail (NCT NCT04036396)

NCT ID: NCT04036396

Last Updated: 2026-02-02

Results Overview

Defined as the participant identifying and completing an appointment with a primary care provider who is willing and able to prescribe HIV pre-exposure prophylaxis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 233 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2026-02-02

Participant Flow

Participants were recruited through a variety of methods, including direct recruitment at supportive housing facilities in LA County and in MCJ, referrals from community partners, participant referrals, and flyers posted by community organizations.

Participant milestones

Measure	Standard of Care A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Overall Study STARTED	117	116
Overall Study COMPLETED	86	87
Overall Study NOT COMPLETED	31	29

Reasons for withdrawal

Measure	Standard of Care A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Overall Study Withdrawal by Subject	3	3
Overall Study Death	2	2
Overall Study Lost to Follow-up	12	14
Overall Study Determined ineligible after enrollment	14	10

Baseline Characteristics

Mobile Enhanced Prevention Support for People Leaving Jail

Baseline characteristics by cohort

Measure	Standard of Care n=103 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=105 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program	Total n=208 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 7.6 • n=13 Participants	32.5 years STANDARD_DEVIATION 6.6 • n=15 Participants	33.5 years STANDARD_DEVIATION 7.2 • n=28 Participants
Sex/Gender, Customized Gender identity · Cisgender male	90 Participants n=13 Participants	88 Participants n=15 Participants	178 Participants n=28 Participants
Sex/Gender, Customized Gender identity · Trans female	8 Participants n=13 Participants	11 Participants n=15 Participants	19 Participants n=28 Participants
Sex/Gender, Customized Gender identity · Gender non-binary or non-conforming	4 Participants n=13 Participants	5 Participants n=15 Participants	9 Participants n=28 Participants
Sex/Gender, Customized Gender identity · Other	1 Participants n=13 Participants	1 Participants n=15 Participants	2 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · American Indian or Alaska Native	1 Participants n=13 Participants	1 Participants n=15 Participants	2 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · Asian	2 Participants n=13 Participants	2 Participants n=15 Participants	4 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · Black or African American	26 Participants n=13 Participants	27 Participants n=15 Participants	53 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic or Latino	47 Participants n=13 Participants	40 Participants n=15 Participants	87 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	3 Participants n=15 Participants	3 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · White	18 Participants n=13 Participants	26 Participants n=15 Participants	44 Participants n=28 Participants
Race/Ethnicity, Customized Race/ethnicity · Other (usually multiple)	9 Participants n=13 Participants	6 Participants n=15 Participants	15 Participants n=28 Participants
Region of Enrollment United States	103 participants n=13 Participants	105 participants n=15 Participants	208 participants n=28 Participants

PRIMARY outcome

Timeframe: 9 months

Defined as the participant identifying and completing an appointment with a primary care provider who is willing and able to prescribe HIV pre-exposure prophylaxis.

Outcome measures

Measure	Standard of Care n=93 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=99 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis)	82 Participants	90 Participants

PRIMARY outcome

Timeframe: 9 months

Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication

Outcome measures

Measure	Standard of Care n=86 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=87 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Initiate PrEP Regimen	12 Participants	28 Participants

PRIMARY outcome

Timeframe: 3, 6, or 9 months

Population: Sample is based on the number of people who reported taking PrEP (14 for Standard of care; 28 for MEPS) but excludes those who declined to respond to the adherence question.

Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week at first instance of reporting taking PrEP

Outcome measures

Measure	Standard of Care n=11 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=26 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Demonstrate Minimal Adherence to PrEP	10 Participants	26 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Sample is based on the number of people who reported taking PrEP (14 for Standard of care; 28 for MEPS) but excludes those who declined to respond to the this question.

The outcomes is defined by self-reported PrEP use for 3 or more months

Outcome measures

Measure	Standard of Care n=11 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=27 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Remain on PrEP for at Least 3 Months.	7 Participants	17 Participants

PRIMARY outcome

Timeframe: 3, 6, and 9 months

Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up

Outcome measures

Measure	Standard of Care n=84 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=86 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up 3 months	44 Participants	55 Participants
Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up 6 months	32 Participants	50 Participants
Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up 9 months	31 Participants	33 Participants

PRIMARY outcome

Timeframe: 6 and 9 months

Defined by the participant self-reporting having obtained testing for these sexually transmitted diseases (STDs) within the 6 months prior to a follow-up over the 9 month follow-up period

Outcome measures

Measure	Standard of Care n=78 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=76 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up 9 months	28 Participants	29 Participants
Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up 3 months	33 Participants	41 Participants
Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up 6 months	32 Participants	40 Participants

PRIMARY outcome

Timeframe: 9 months

Defined by the participant self-reporting having obtained at least one test for Hepatitis C

Outcome measures

Measure	Standard of Care n=93 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=99 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Undergo a Test for Hepatitis C	80 Participants	85 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Sample based on the first 3-month followup and excluding participants who skipped the question

Defined by the participant self-report of completing SUD appointments within the 3 months following enrollment

Outcome measures

Measure	Standard of Care n=84 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=86 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Obtaining Treatment for Substance Use Disorders (SUDs) in the Community	25 Participants	23 Participants

PRIMARY outcome

Timeframe: 9 months

Defined by the participant self-reporting remaining engaged in treatment (i.e., continuing to attend meetings, counseling or other treatment activities) in the 3 months prior to the final follow-up interview.

Outcome measures

Measure	Standard of Care n=86 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=87 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Remain Engaged in Treatment for Substance Use Disorders (SUDs) in the Community,	11 Participants	4 Participants

SECONDARY outcome

Timeframe: 3, 6, or 9 months

Population: Outcome is among those who acquired HIV or HCV during the study.

Self-report of whether or not participants received follow-up care and treatment for HIV or hepatitis C infections diagnosed during study follow-up (n=200)

Outcome measures

Measure	Standard of Care n=4 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=4 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections.	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 9 months

Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated.

Outcome measures

Measure	Standard of Care n=93 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=99 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Participants Who Recidivate	29 Participants	35 Participants

SECONDARY outcome

Timeframe: 9 months

Population: Outcome is among those who were reincarcerated at some point during the study.

Measure the comparative effectiveness of the intervention reducing recidivism (n=200), quantified as total number of reincarcerations over the study period among those who recidivate.

Outcome measures

Measure	Standard of Care n=29 Participants A client-centered assessment of priorities and needs and customized prevention and testing referrals.	Mobile Enhanced Prevention Support n=35 Participants Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Number of Reincarcerations Among Those Who Recidivate	1 reincarcerations Interval 1.0 to 2.0	2 reincarcerations Interval 1.0 to 2.0

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Mobile Enhanced Prevention Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nina Harawa

University of California, Los Angeles

Phone: 310-794-8078

Email: nharawa@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place