NCT02107911

Brief Summary

The potential participants will be informed of the study details, including the study objectives. Once they have read the study information sheet and have a good understanding of the study, those who intend to participate in the study will be asked to sign the consent form for this study. There are 2 groups of participants: MSM who seek HIV voluntary counseling and testing service (phase I) and MSM who meet nPEP criteria (phase II).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

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

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

9 months

First QC Date

April 4, 2014

Last Update Submit

May 27, 2015

Conditions

Keywords

men who have sex with mennon-occupational post exposure prophylaxisHIV infection

Outcome Measures

Primary Outcomes (1)

  • Intention to take nPEP

    1 day

Secondary Outcomes (3)

  • Knowledge and awareness regarding nPEP

    1 day

  • Knowledge and awareness about HIV risk behaviors

    1 day

  • Stigma and discrimination towards HIV

    1 day

Study Arms (1)

men who have sex with men

MSM who seek voluntary HIV counseling and testing service at the Anonymous Clinic, TRC-ARC, including those who describe risky sexual exposure to HIV within the preceding 72 hours and meet nPEP criteria.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSM who seek voluntary HIV counseling and testing service at the Thai Red Cross AIDS Research Centre, including those who describe risky sexual exposure to HIV within the preceding 72 hours and meet nPEP criteria.

You may qualify if:

  • Thai MSM seeking HIV voluntary counseling and testing at the Anonymous Clinic, TRC-ARC.
  • Age \>18 years old.
  • Read and understand the study and document their consent on the informed consent form.

You may not qualify if:

  • Any individual who has any medical or psychological conditions, including drug or alcohol addiction that the physician or counselor feels may interfere with his ability to participate in the study or cannot provide adequate information.
  • Any MSM who is already receiving antiretroviral therapy for the prevention of HIV infection after exposure to HIV.
  • Phase II
  • Thai MSM who meet nPEP criteria
  • Document their consent on the informed consent form of in-depth interview
  • Cannot come to the clinic according to the schedule visit
  • Individual who has any medical or psychological conditions, including drug or alcohol addiction that the investigator feels may interfere with his ability to attend study visits or cannot provide the information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SEARCH, the Thai Red Cross AIDS Research Centre

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HomosexualityHIV Infections

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Nitiya - Chomchey, MSc

    SEARCH, the Thai Red Cross AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.Nitiya Chomchey, RN, MSc

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations