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Completed

NCT Number: NCT05091489

ANRS 12415 - Quali PrEP 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

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences

Phnom Penh, Cambodia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualitative assessment about PrEP acceptability

Other

Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews

Primary outcomes

  1. Knowledge about PrEP

    Time frame: 1 hour

    qualitative assessement

  2. Perception of PrEP

    Time frame: 1 hour

    qualitative assessement

  3. Acceptability of PrEP

    Time frame: 1 hour

    qualitative assessement

Secondary outcomes

  1. 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

    Time frame: 1 hour

    qualitative assessement

  2. To identify tools that could be useful to increase PrEP awareness and acceptability, especially new technologies (apps, websites)

    Time frame: 1 hour

    qualitative assessement

Sponsors and collaborators

Lead sponsor

Institut de Recherche pour le Developpement

Other Gov

Collaborators

  • National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia
  • University of Health Sciences, Phnom Penh, Cambodia

Registry information

Official study title

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

Acronym: ANRS 12415

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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