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Clinical Trials/NCT02749955
NCT02749955CompletedNot Applicable

Partner Services Pre-exposure Prophylaxis (PS-PrEP)

University of Chicago2 sites in 1 country164 target enrollmentStarted: November 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
164
Locations
2
Primary Endpoint
Timing of linkage to care after behavioral intervention

Study Overview

Brief Summary

This study evaluates the feasibility (reach, adoption, safety and implementation) and initial efficacy (higher linkage to care) of the Partner Services Pre-exposure Prophylaxis (PS-PrEP) intervention versus phone based Pre-exposure Prophylaxis (PrEP) treatment at 3 months post randomization among a sample of high risk individuals 18 - 35 years from clinic-based recruitment and internal referrals from social network based projects. The evaluation of the intervention will be used to strengthen routine department of public health services linkage to PrEP care.

Detailed Description

The investigators will enroll 150 human immunodeficiency virus (HIV) seronegative contacts presenting to sexually transmitted infections (STI) clinics for HIV testing and referrals from the Chicago Center for HIV Elimination (CCHE) network-based projects, ages 18 - 35, in this study over a period of 18 months referred from University of Chicago clinics and outreach space that perform HIV Partner Services as well as Expanded HIV testing and Linkage to Care (XTLC) and Chicago Department of Public Health (CDPH) partner notification services on the South Side of Chicago.

Eligible participants will undergo consent and complete the baseline assessment within 14 days of eligibility. Subjects will be taken through the baseline assessment includes survey modules described in detail below (demographics, substance use, mental health and stigma). At the baseline visit, the investigators will collect data on demographics and sex and drug-using risk variables. From the common electronic medical record at both clinics, the investigators will collect data on participants' care providers and health care utilization. Subjects will be asked to sign a medical release form.

Whenever possible, the investigators selected measures: (1) previously tested in HIV implementation studies, particularly among younger and minority populations and (2) to maximize comparability to other studies.

Randomization Following the baseline assessment, study participants will be randomized into one of two groups: the Partner Services Pre-exposure Prophylaxis (PS-PrEP) intervention group or the standard of care practice PrEPLine control condition. Study staff will discuss pros and cons, ethical basis of assigning participants to different arms of a study, of control and intervention with participants (equipoise induction) to balance the desirability of the two intervention conditions. Block randomization will be used for allocation to ensure balanced representation in the two treatment arms (control and intervention) as recruitment progresses. The randomization assignment will be generated using the R program. Once randomized, each participant will be given a study identification number and will be allocated to their respective study condition to begin the trial. Due to the nature of this intervention, complete masking of participants, investigators, and interventionist is not possible. The research staff will work directly with the linkage and support group. To help mitigate possible bias in interviewing, baseline data collection will occur prior to randomization.

After randomization, those who are in the intervention group will be taken through the Session I of the intervention. This may take place on the same day as the consent and baseline visit, or it may be scheduled at a different time depending the subject's availability.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • HIV seronegative and completed post-test counseling
  • Eligible for PrEP according to the package insert
  • 18 - 35 years of age
  • African American/Black identified MSM
  • English speaking
  • Owns a cell phone not shared with other persons
  • Agreeable to text/phone mini-booster sessions; and
  • Lives in the Chicago metropolitan area for more than 6 months annually

Exclusion Criteria

  • Taking or taken PrEP in the previous 12 months
  • Unable to provide consent
  • Plan to move out of the are

Outcomes

Primary Outcomes

Timing of linkage to care after behavioral intervention

Time Frame: One Year

At 6 and 12 months linkage to care will be compared

Surveying the uptake of PrEP care after randomized behavioral intervention or routine linkage

Time Frame: One Year

Comparing 60 individuals who receive enhanced personalized linkage to care with a social worker to 60 individuals who receive routine phone based PrEP linkage.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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