Ongoing Study: Recruiting Study Participants

Status: Recruiting study participants
A Research Study Designed to Determine the Rate of New HIV Infections Among
Men Who Have Sex With Men In Urban Cities
Sponsor:
Philippine Council for Health Research and
Development, Department of Science and Technology
Collaborator:
Research Institute for Tropical Medicine, Department
of Health
Information provided by Dr. Rossana A. Ditangco, MD, Research Institute for
(Responsible Party): Tropical Medicine
RITM Institutional Review
2011-29-0
Board Protocol Number :
Purpose
There is very little information on how fast HIV is spreading among men who have sex
with men in urban cities, specifically in Metro Manila. In this study, participants will
undergo HIV antibody testing every 3 months for 3 to 5 years to find out the proportion
that will acquire new HIV infection during the study period. Participants will also be
tested and treated for other sexually transmitted infections. Every follow up visit,
participants will be provided with HIV prevention education and commodities.
Condition
MSM unknown HIV status or HIV negative
during last test
Study Type:
Intervention
HIV antibody test every 3 months for 3
to 5 years
Cohort observational
Study Design:
Endpoint Classification: sero-conversion
Primary Purpose: HIV incidence
Official Title:
Incidence of HIV in a cohort of men who have sex with men in Metro
Manila
Further study details as provided by the Research Institue for Troipical Medicine :
Primary Outcome Measures: HIV sero-conversion
Enrollment:
620 participants
Study Start Date:
November 15, 2013
Study Completion Date:
December 2017
Primary Completion Date:
December 2017 (Final data collection date for primary
outcome measure)
Detailed Description:
In recent years, a significant increase in the number of new HIV infections are being
observed and majority of new HIV infections are being reported among young men who
have sex with men (MSM) from highly urbanized areas in the country. There is no
concrete data on the incidence of HIV among MSM that could better describe the burden
of disease and assess the impact of on-going interventions. Implementing a cohort study
on the incidence of HIV will not only help describe the current rates of infections among
MSM but will also provide the research infrastructure for future research on molecular
epidemiology of HIV and pathogenesis that are the backbone of vaccine, treatment and
other prevention research. The primary objective of this research is to determine the
incidence of HIV in a cohort of men who have sex with men (MSM) in Metro Manila.
Other objectives are to describe the characteristics, behaviors, practices, knowledge,
attitude and perception on HIV of MSM and factors associated with HIV.
The Informed Consent Document contains all the required elements of informed consent
as required by the institutional and ethical review board of RITM. The consent clearly
states that this is research, participation is voluntary, and participants’ record and data
will be protected to ensure confidentiality, that participants will be informed of the results
of tests for sexually transmitted infections and appropriate management will be given and
in case of positive HIV tests results, they will be immediately referred to RITM for HIV
management. During each follow- up visit, participants will be provided with HIV
prevention education and commodities. The participants will not incur cost with their
participation, and that the laboratory tests that are part of the study (screening for STIs
and HIV) are free and they will be provided with reasonable amount to cover their
transportation expense for the follow up visits.
Eligibility
Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers:
18 Years and older
Male
Yes
Criteria
 Inclusion Criteria: 1. MSM who had anal or oral sex in the past 12 months

2. 18 years old and above

3. resides within Metro Manila

4. willing to follow-up every 3 months for 3 to 5 years
Exclusion Criteria:

known HIV infected or had a confirmed positive HIV antibody test

Contacts and Locations
Ms. Nikka Martinez or Ms. Hazel Macato # 09178261994, 3538922
Locations
Philippines, Metro Manila
RITM Satellite Clinic/The Love yourself Hub
1850 Leon Guinto St. Malate Manila
Sponsors and Collaborators
Philippine Council for Health Research and Development, Department of Science and
Technology
Research Institute for Tropical Medicine, Department of Health
Investigators
Principal
Investigator:
Rossana A.
Ditangco,MD
Research Institute for Tropical
Medicine