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| ID | Type | Description | Link |
|---|---|---|---|
| OS17-LA-003 | Other Grant/Funding Number | California HIV/AIDS Research Program |
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| Name | Class |
|---|---|
| Los Angeles Centers For Alcohol and Drug Abuse | UNKNOWN |
| Charles Drew University of Medicine and Science | OTHER |
| California HIV/AIDS Research Program | OTHER |
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This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.
The investigators will enroll 200 people in jail or within 12 months post-release from incarceration. During the trial, half of participants will be randomized into a control group that will receive usual care consistent with the setting in which they live, along with referrals customized to their needs and preferences to share with a case manager. They will be compared to the other half of participants randomized to the intervention group that, in addition to receiving customized referral sources, will also receive the GeoPassport App, incentives, and the support of a trained Peer Mentor for six months. The GeoPassport App will provide participants with tools for tracking goals and progress toward meeting them, assistance in locating services, appointment and medication reminders, opportunities to provide feedback on service providers, and built-in tracking and distribution of rewards (incentives) for service utilization. GeoPassport will assist Peer Mentors in monitoring participants' service utilization. The Peer Mentors will provide encouragement, role modeling, accompaniment to appointments, and assistance with goal setting, problem-solving, and reducing logistical and psychosocial barriers to service engagement. The intervention can be delivered in person or remotely in order to comply with necessary social distancing during the COVID-19 pandemic. Participants in both groups will be followed to assess whether those offered the intervention are more likely to meet the specific prevention targets described in the Specific Aims. The intervention lasts 6 months from the start of participation. Participants are interviewed at 3, 6, and 9 months from the same point as the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | A client-centered assessment of priorities and needs and customized prevention and testing referrals. |
|
| Mobile Enhanced Prevention Support | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Enhanced Prevention Support | Behavioral | Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis) | 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. | 9 months |
| Number of Participants Who Initiate PrEP Regimen | Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication | 9 months |
| Number of Participants Who Demonstrate Minimal Adherence to PrEP | Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week at first instance of reporting taking PrEP | 3, 6, or 9 months |
| Number of Participants Who Remain on PrEP for at Least 3 Months. | The outcomes is defined by self-reported PrEP use for 3 or more months | 9 months |
| Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up | Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up | 3, 6, and 9 months |
| Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up | 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 | 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections. | 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) | 3, 6, or 9 months |
| Number of Participants Who Recidivate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Self-identifies as a man or a male-to-female trans woman.
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| Name | Affiliation | Role |
|---|---|---|
| Nina T Harawa, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| God's Property | Los Angeles | California | 90003 | United States | ||
| Los Angeles County Men's Central Jail |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40634829 | Derived | Schrode KM, Edwards GG, Moghanian B, Weiss RE, Reback CJ, McWells C, Hilliard CL, Harawa NT. Randomized Controlled Trial Testing an HIV/STI Prevention Intervention Among People Leaving Incarceration Who Were Assigned Male at Birth, Have Sex with Men and A Substance Use Disorder. AIDS Behav. 2025 Dec;29(12):3806-3821. doi: 10.1007/s10461-025-04818-4. Epub 2025 Jul 10. | |
| 32959786 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | A client-centered assessment of priorities and needs and customized prevention and testing referrals. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were enrolled and began the study but were later determined to be ineligible are excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | A client-centered assessment of priorities and needs and customized prevention and testing referrals. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis) | 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. | Posted | Count of Participants | Participants | 9 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | A client-centered assessment of priorities and needs and customized prevention and testing referrals. Usual Care plus Customized Referrals: Participants in the control arm will continue to receive services they would normally receive consistent with the setting in which they were recruited. This includes substance use treatment in jail, substance use treatment at a residential recovery facility, and/or supportive housing services. The study will provide referrals customized to their needs and preferences. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nina Harawa | University of California, Los Angeles | 310-794-8078 | nharawa@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2019 | Dec 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2023 | Jan 7, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D006526 | Hepatitis C |
| D019966 | Substance-Related Disorders |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Friends Research Institute, Inc. |
| OTHER |
The Mobile Enhanced Prevention Support (MEPS) intervention is designed to support, motivate, and facilitate engagement in preventive health care activities in the period of community reentry following jail. Three components: support from a selected Peer Mentor (PM), incentives, and a developed mobile application. Client-driven approach, in which participants are encouraged to address priorities and immediate needs for that they identify a client-centered needs assessment, prioritization, and wellness planning process, especially social determinants of health that may discourage or undermine preventive health measures.
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|
| Usual Care plus Customized Referrals | Behavioral | Participants in the control arm will continue to receive services they would normally receive consistent with the setting in which they were recruited. This includes substance use treatment in jail, substance use treatment at a residential recovery facility, and/or supportive housing services. The study will provide referrals customized to their needs and preferences. |
|
| Number of Participants Who Undergo a Test for Hepatitis C |
Defined by the participant self-reporting having obtained at least one test for Hepatitis C |
| 9 months |
| Number of Participants Obtaining Treatment for Substance Use Disorders (SUDs) in the Community | Defined by the participant self-report of completing SUD appointments within the 3 months following enrollment | 3 months |
| Number of Participants Who Remain Engaged in Treatment for Substance Use Disorders (SUDs) in the Community, | 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. | 9 months |
Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated. |
| 9 months |
| Number of Reincarcerations Among Those Who Recidivate | 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. | 9 months |
| Los Angeles |
| California |
| 90012 |
| United States |
| Los Angeles Center for Alcohol and Drug Abuse | Santa Fe Springs | California | 90670 | United States |
| Edwards GG, Reback CJ, Cunningham WE, Hilliard CL, McWells C, Mukherjee S, Weiss RE, Harawa NT. Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 22;9(9):e18106. doi: 10.2196/18106. |
| Lost to Follow-up |
|
| Determined ineligible after enrollment |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Number of Participants Who Initiate PrEP Regimen | Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Primary | Number of Participants Who Demonstrate Minimal Adherence to PrEP | Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week at first instance of reporting taking PrEP | 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. | Posted | Count of Participants | Participants | 3, 6, or 9 months |
|
|
|
|
| Primary | Number of Participants Who Remain on PrEP for at Least 3 Months. | The outcomes is defined by self-reported PrEP use for 3 or more months | 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. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Primary | Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up | Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up | Posted | Count of Participants | Participants | 3, 6, and 9 months |
|
|
|
|
| Primary | Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up | 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 | Posted | Count of Participants | Participants | 6 and 9 months |
|
|
|
|
| Primary | Number of Participants Who Undergo a Test for Hepatitis C | Defined by the participant self-reporting having obtained at least one test for Hepatitis C | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Primary | Number of Participants Obtaining Treatment for Substance Use Disorders (SUDs) in the Community | Defined by the participant self-report of completing SUD appointments within the 3 months following enrollment | Sample based on the first 3-month followup and excluding participants who skipped the question | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| Primary | Number of Participants Who Remain Engaged in Treatment for Substance Use Disorders (SUDs) in the Community, | 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. | Posted | Count of Participants | Participants | 9 months |
|
|
|
|
| Secondary | Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections. | 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 is among those who acquired HIV or HCV during the study. | Posted | Count of Participants | Participants | 3, 6, or 9 months |
|
|
|
| Secondary | Number of Participants Who Recidivate | Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | Number of Reincarcerations Among Those Who Recidivate | 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 is among those who were reincarcerated at some point during the study. | Posted | Median | Inter-Quartile Range | reincarcerations | 9 months |
|
|
|
| 2 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | 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 Mobile Enhanced Prevention Support: Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor. Usual Care plus Customized Referrals: Participants in the control arm will continue to receive services they would normally receive consistent with the setting in which they were recruited. This includes substance use treatment in jail, substance use treatment at a residential recovery facility, and/or supportive housing services. The study will provide referrals customized to their needs and preferences. | 2 | 116 | 0 | 116 | 0 | 116 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 9 months |
|
6 month follow-up |
| Superiority |
| Mixed Models Analysis | 0.6910 | 9 month follow-up | Superiority |
| 9 months |
|
6 month follow-up |
| Superiority |
| Mixed Models Analysis | 9 month follow-up | 0.9283 | Superiority |