ANRS 12415 - Quali PrEP Cambodia

NCT ID: NCT05091489

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-05-15

Brief Summary

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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

Detailed Description

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Conditions

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Hiv

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Men who have sex with men (MSM) non-using PrEP

Focus group (10 persons)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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)

Qualitative assessment about PrEP acceptability

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Health Sciences, Phnom Penh, Cambodia

UNKNOWN

Sponsor Role collaborator

National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia

UNKNOWN

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marion Fiorentino

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vonthanak SAPHONN

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences (UHS)

Locations

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University of Health Sciences

Phnom Penh, , Cambodia

Site Status

Countries

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Cambodia

Other Identifiers

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PREP2021-MF

Identifier Type: -

Identifier Source: org_study_id

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