NCT01720641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

October 29, 2012

Last Update Submit

August 4, 2014

Conditions

Keywords

MSMTransgender WomenPartner NotificationSyphilisPeru

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Partner Notification

    Participant self-report of recent partner notification at 14-21 days of follow-up.

    21 days

Secondary Outcomes (1)

  • Investigator-confirmed Partner Notification

    21 Days

Study Arms (4)

Control

NO INTERVENTION

Standardized partner notification counseling

Internet Notification

EXPERIMENTAL

Standardized partner notification counseling and referral to internet-based partner referral website.

Behavioral: Internet

Referral Card

EXPERIMENTAL

Standardized partner notification counseling and provision of 5 printed partner referral cards.

Behavioral: Referral Card

Internet and Referral Card

EXPERIMENTAL

Standardized partner notification counseling and referral to internet-based partner referral website and provision of 5 printed partner referral cards.

Behavioral: Internet and Referral Card

Interventions

InternetBEHAVIORAL

Referral and user instructions for Peru section of www.inspot.org partner notification website

Internet Notification
Referral CardBEHAVIORAL

5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources.

Referral Card

5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources; Referral and user instructions for Peru section of www.inspot.org partner notification website.

Internet and Referral Card

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years of age
  • Unable to understand informed consent procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Civil Impacta Salud y Educacion

Lima, Peru

Location

Related Publications (2)

  • Clark JL, Segura ER, Oldenburg CE, Salvatierra HJ, Rios J, Perez-Brumer AG, Gonzales P, Sheoran B, Sanchez J, Lama JR. Traditional and Web-Based Technologies to Improve Partner Notification Following Syphilis Diagnosis Among Men Who Have Sex With Men in Lima, Peru: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Jul 3;20(7):e232. doi: 10.2196/jmir.9821.

  • Braun HM, Segura ER, Lake JE, Gandhi M, Rios J, Villaran MV, Sanchez J, Lama JR, Clark JL. Individual and partnership factors associated with anticipated versus actual partner notification following STI diagnosis among men who have sex with men and/or with transgender women in Lima, Peru. Sex Transm Infect. 2018 Dec;94(8):607-610. doi: 10.1136/sextrans-2017-053292. Epub 2017 Nov 30.

MeSH Terms

Conditions

Syphilis

Interventions

Patient Portals

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Health Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Jesse L Clark, MD, MSc

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor-in-Residence

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 2, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations