Partner Notification Strategies for STI Control in Urban Peru
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- Self-Reported Partner Notification
Study Overview
Brief Summary
The goal of the proposed research is to assess new strategies for partner management and sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the core risk group of MSM. STI infection and re-infection are central to the continuation of the HIV epidemic among MSM in Peru. Development of improved strategies for partner notification and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the incidence of HIV infection in this population. The first phase of this study used qualitative methods to explore attitudes and practices related to partner notification among MSM in Lima, Peru. Findings from the qualitative research were used to develop a quantitative survey instrument to assess partner notification decision-making processes and practices among MSM in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and qualitative phases of the study have been used to develop a partner notification for MSM in Peru. Investigators plan to implement and assess the impact of the intervention on rates of partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The investigators hypothesize that participants randomized to receive one or more partner notification tools will report a higher frequency of partner notification.
Detailed Description
Specific Aim: To assess the efficacy of internet- and referral card-based partner notification tools for the improvement of partner notification outcomes among MSM in Lima, Peru. As attitudes and behaviors related to partner notification vary within specific behavioral, social, and clinical contexts, interventions designed to improve partner notification outcomes must address the same contextual determinants to be effective. Partner notification tools based on electronic distribution of anonymous notification messages and/or patient-delivered referral cards are expected to increase notification rates in specific contexts.
Hypothesis: Provision of partner notification tools based on electronic and printed resources will improve reported and observed partner notification outcomes by overcoming barriers to notification including limited contact information, fear of disclosure, stigma, and lack of informational resources. Notification outcomes and use of notification tools will vary according to strategies of interpersonal communication reflected in the specific behavioral, social, and biomedical contexts of the individual, the partnership, and the STI diagnosed.
Participants will be selected for participation in the study depending on the findings of the EPT/Partner Notification Screening Protocol. Participants in the EPT/Partner Notification Screening Protocol diagnosed with new syphilis infection will be eligible for enrollment in the Partner Notification protocol.
I. Recruitment: Participants in the EPT/Partner Notification Screening Protocol who are diagnosed with syphilis based on physician interpretation of results of RPR assay and clinical history will be invited by the Study Counselor to participate in the Partner Notification Intervention Protocol.
II. Informed Consent: All potential subjects will receive an explanation of the study procedures and risks and benefits and asked to provide written Informed Consent. Participants will be given the opportunity to take the Informed Consent Document home for further review and decide at a later time if they wish to participate in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Male or biologically male at birth
- •Sexual contact (oral or anal intercourse) with a male or male-to-female transgender partner in the past 12 months
- •Diagnosis with syphilis infection
Exclusion Criteria
- •Under 18 years of age
- •Unable to understand informed consent procedures
Arms & Interventions
Control
Standardized partner notification counseling
Internet Notification
Standardized partner notification counseling and referral to internet-based partner referral website.
Intervention: Internet (Behavioral)
Referral Card
Standardized partner notification counseling and provision of 5 printed partner referral cards.
Intervention: Referral Card (Behavioral)
Internet and Referral Card
Standardized partner notification counseling and referral to internet-based partner referral website and provision of 5 printed partner referral cards.
Intervention: Internet and Referral Card (Behavioral)
Outcomes
Primary Outcomes
Self-Reported Partner Notification
Time Frame: 21 days
Participant self-report of recent partner notification at 14-21 days of follow-up.
Secondary Outcomes
- Investigator-confirmed Partner Notification(21 Days)
Investigators
Jesse Clark
Assistant Professor-in-Residence
University of California, Los Angeles