ANRS 12415 - Quali PrEP Cambodia (ANRS 12415)

Qualitative Assessment About PrEP Acceptability in Key-populations and Conditions Required for Community-based PrEP Implementation in Cambodia

Hypothesis:

• Hypothesis 1 : Regarding the recentness of preexposure prophylaxis (PrEP) implementation with an uptake of 20% and according to the first consultative meeting, awareness and acceptability of PrEP seems to be low in key-populations of Cambodia
• Hypothesis 2 : Individual, social and structural barriers and facilitating factors of PrEP implementation as perceived by health workers and community-based organizations would be similar to what was observed worldwide 4,8.
• Hypothesis 3: Some subgroups of key-populations are difficult to reach in health facilities. Community organizations can play a critical role to provide PrEP information, initiation and counselling with the support of new technologies.
• Hypothesis 4: Community organizations might lack financial, logistical and skill capacities to deliver PrEP in good conditions

Main objective:

• To qualitatively evaluate the knowledge, awareness, perception, experience and acceptability of PrEP among key populations (entertainment workers (EW), men who have sex with men (MSM), transgender women (TW)), and among healthcare and community workers in charge of key populations

Secondary objectives:

• To better understand the characteristics, needs and expectations of community-based organizations (CBOs), in order to define the optimal conditions for community-based PrEP implementation
• To identify tools that could be useful to increase PrEP awareness and acceptability, especially new technologies (apps, websites)

Methodology: Qualitative study Focus groups with key-populations, healthcare and community workers Semi-directive interviews with decision makers and policy makers Estimated enrolment: 10 participants per focus group, 8 focus groups, 80 participants in focus groups, 6 interviewed persons, 86 participants in total

Study population: Men who have sex with men (MSM), entertainment workers (EW), transgender women (TGW), healthcare workers, community workers, decision and policy makers

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Other: Qualitative assessment about PrEP acceptability

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

MSM, TGW, MEW, FEW will be recruited through community-based organisations, or online, or directly on hotspots.

PrEP users will be recruited through the pilot program "Khmer PrEP" or online or through community-based organisations or directly on hotspots.

Health workers will be recruited in HIV services targeting key-populations. Decision makers will be recruited in their organizations respectively.

Description

Eligibility criteria for key-populations included in focus groups

• All key-populations

  • Having consented to participate into the research
  • Self-declared negative HIV status
• Men who have sex with men (MSM): being sexually active and having had anal sex with at least one male (including TGW women) partner in the past 12 months.
• Transgender women (TGW): Being biologically male at birth and self-identified as a woman or third gender, reporting having anal sex with at least one male in the past 12 months
• Male entertainment workers (MEW): having at least one sexual intercourse in exchange of money in the last month. MEW are engaged in transactional sex by Facebook, via online App (Grinder, Blue) and massage parlor.
• Female entertainment workers: Venue-based (work in entertainment establishment) or non-venue based (freelance/street-based or park-based) women having at least one sexual intercourse in exchange of money in the last month. Venue-based EW (VEW) are defined as EW engaged in transactional sex for supplementary income which are employees in entertainment venues such as karaokes, bars, beer gardens, massage parlours. Free-lance EW (FEW) are defined as EW engaged in transactional sex in short-time hotel or public parks21 or "high-class" EW working in salons or using apps such as Line. We hypothesized that FEW and VEW have different sex behaviours as well as different perceptions and motivations towards PrEP.
• PrEP users: MSM or TGW who have started medical PrEP in the pilot program "Khmer PrEP" and MSM or TGW who have independently started medical PrEP in private. If possible, individuals who are currently receiving PrEP and individuals who discontinued will be included.

Exclusion criteria for key-populations : self-declared HIV-positive

Eligibility criteria for community and health workers

• Health workers and counselors: 1/ currently working in a HIV service targeting key populations (Samdach Ov Referral Hospital, Meanchey Referral Hospital, Social Health Clinic). 2/ currently working in a health service delivering PrEP (Chhouk Sar Clinic, Pochentong and Chaktomuk hospitals, RHAC)
• Community workers: currently working in CBOs with EW, TG and/or MSM (Cambodian Women for Peace and Development (CWPD), Men's Health Cambodia (MHC), Men's Health Social Service (MHSS)

Individual semi-directive interviews will be conducted:

• NCHADS (operational unit of the Ministry of Health in charge of health sector policy development for HIV/AIDS)
• National Aids Authority: in charge to lead, manage, coordinate and facilitate the comprehensive and multi-sectoral response to HIV and AIDS in Cambodia
• Ministry of Health
• Key influencer in the MSM and/or TG community
• Key influencer in the EW community
• Khana : an umbrella organization belonging to the HIV/AIDS international Alliance.
• High class and hidden MSM
• Discontinued PrEP user

Study Plan

How is the study designed?

Number of groups / cohorts

16

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men who have sex with men (MSM) non-using PrEP; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Male entertainment workers; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Free-lance based entertainment female workers non-using PrEP; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Venue-based entertainment female workers non-using PrEP; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Transgender women (TGW) non-using PrEP; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Healthcare workers in charge of key-populations; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Community workers in charge of key-populations; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
PrEP users; Focus group (10 persons)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
NCHADS; Individual semi-directive interview (1 person) (NCHADS: operational unit of the Ministry of Health in charge of health sector policy development for HIV/AIDS)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
National Aids Authority; Individual semi-directive interview (1 person) (National Aids Authority: in charge to lead, manage, coordinate and facilitate the comprehensive and multi-sectoral response to HIV and AIDS in Cambodia)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Ministry of Health; Individual semi-directive interview (1 person)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Key influencer in the MSM and/or TGW community; Individual semi-directive interview (1 person)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Key influencer in the EW community; Individual semi-directive interview (1 person)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Khana; Individual semi-directive interview (1 person) Khana : an umbrella organization belonging to the HIV/AIDS international Alliance	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
High class and hidden MSM; Individual semi-directive interview (1 person)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
Discontinued PrEP user; Individual semi-directive interview (1 person)	Other: Qualitative assessment about PrEP acceptability; Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about PrEP	qualitative assessement	1 hour
Perception of PrEP	qualitative assessement	1 hour
Acceptability of PrEP	qualitative assessement	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To better understand the characteristics, needs and expectations of community-based organisations (CBOs), in order to define the optimal conditions for community-based PrEP implementation	qualitative assessement	1 hour
To identify tools that could be useful to increase PrEP awareness and acceptability, especially new technologies (apps, websites)	qualitative assessement	1 hour

Collaborators and Investigators

• Sponsor: Institut de Recherche pour le Developpement
• Collaborators: University of Health Sciences, Phnom Penh, Cambodia; National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia
• Investigators: Principal Investigator: Vonthanak SAPHONN, University of Health Sciences (UHS)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: PrEP; prevention; Men who have sex with men (MSM); men who have sex with men; Cambodia; acceptability; focus group; Healthcare; qualitative; Sex workers; Transgender women (TGW); interview; Community-based organisations; Pre-exposition prophylaxis; decision makers; community workers
• Other Study ID Numbers: PREP2021-MF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No