Factors Affecting the Intention to Take nPEP Among Thai MSM

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by South East Asia Research Collaboration with Hawaii
Sponsor:
Information provided by (Responsible Party):
Nitiya Chomchey, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT02107911
First received: April 4, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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).

Phase I. MSM who seek HIV voluntary counseling and testing

  1. All MSM clients will be interviewed to complete the questionnaires designed to collect information for this study before the pre-test counseling. The questions will collect demographic data and data regarding HIV risk behaviors, HIV knowledge, intention to take nPEP, factors affecting the intention to take nPEP, experience on nPEP use, and awareness of nPEP.
  2. After MSM clients receive the counseling. They will be interviewed to answer the questionnaires about HIV knowledge, intention to take nPEP, factor affecting to intention to take nPEP, nPEP knowledge.
  3. All MSM clients will receive pre-test counseling, HIV testing, and post-test counseling according to the standard of care at the Anonymous Clinic, TRC-ARC. Counselors will also assess clients for nPEP eligibility criteria according to the standard clinic guidelines.

Phase II. MSM who receive nPEP

  1. Participant who describes a history of an HIV risk exposure within the preceding 72 hours and meets nPEP eligibility criteria as assessed by the clinic counselor. After participants receive all information to know whether they receive antiretroviral medication, they can decide by themselves about taking medication. The participant who select to take nPEP will receive a 14-day supply of nPEP medication and will be scheduled back to receive the rest of their medication.
  2. Both participant who decide to take and not take nPEP will be asked to take part in the in-depth interviews to examine factors affecting the decision to use nPEP.
  3. At week 6, the participants who take nPEP will be evaluated for HIV infection, adherence to medication during the 28-day course of nPEP, side effects from nPEP and asked to be interviewed about risk behaviors and other HIV prevention methods since the start of nPEP.

At each of these study visits, the participant will receive risk reduction counseling along with the provision of condoms and lubricant


Condition
Intention to Take Non-occupational Post Exposure Prophylaxis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Factors Affecting the Intention to Take Non-occupational HIV Post-exposure Prophylaxis Among Thai Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:
  • Intention to take nPEP [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge and awareness regarding nPEP [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Knowledge and awareness about HIV risk behaviors [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Stigma and discrimination towards HIV [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
men who have sex with men

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Phase I Inclusion criteria

  • 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.

Exclusion criteria

  • 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 Inclusion criteria

  • Thai MSM who meet nPEP criteria
  • Document their consent on the informed consent form of in-depth interview

Exclusion criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107911

Contacts
Contact: Nitiya - Chomchey, MSc 6622542566 ext - nitiya.c@searchthailand.org

Locations
Thailand
SEARCH, the Thai Red Cross AIDS Research Centre Recruiting
Bangkok, Thailand, 10330
Contact: Nitiya - Chomchey, MSc    6622542566 ext -    nitiya.c@searchthailand.org   
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Investigators
Principal Investigator: Nitiya - Chomchey, MSc SEARCH, the Thai Red Cross AIDS Research Centre
  More Information

No publications provided

Responsible Party: Nitiya Chomchey, Ms.Nitiya Chomchey, RN, MSc, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT02107911     History of Changes
Other Study ID Numbers: SEARCH 020
Study First Received: April 4, 2014
Last Updated: April 4, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by South East Asia Research Collaboration with Hawaii:
men who have sex with men
non-occupational post exposure prophylaxis
HIV infection

ClinicalTrials.gov processed this record on September 11, 2014