NCT05091489

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

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

First Submitted

Initial submission to the registry

September 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 23, 2021

Last Update Submit

September 26, 2023

Conditions

Keywords

Men who have sex with men (MSM)Transgender women (TGW)Sex workersHealthcareCommunity-based organisationsPrEPPre-exposition prophylaxisfocus groupinterviewCambodiaqualitativeacceptabilitypreventionmen who have sex with mendecision makerscommunity workers

Outcome Measures

Primary Outcomes (3)

  • Knowledge about PrEP

    qualitative assessement

    1 hour

  • Perception of PrEP

    qualitative assessement

    1 hour

  • Acceptability of PrEP

    qualitative assessement

    1 hour

Secondary Outcomes (2)

  • 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

    1 hour

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

    1 hour

Study Arms (16)

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

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

Male entertainment workers

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

Free-lance based entertainment female workers non-using PrEP

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

Venue-based entertainment female workers non-using PrEP

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

Transgender women (TGW) non-using PrEP

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

Healthcare workers in charge of key-populations

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

Community workers in charge of key-populations

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

PrEP users

Focus group (10 persons)

Other: Qualitative assessment about PrEP acceptability

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

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

Ministry of Health

Individual semi-directive interview (1 person)

Other: Qualitative assessment about PrEP acceptability

Key influencer in the MSM and/or TGW community

Individual semi-directive interview (1 person)

Other: Qualitative assessment about PrEP acceptability

Key influencer in the EW community

Individual semi-directive interview (1 person)

Other: Qualitative assessment about PrEP acceptability

Khana

Individual semi-directive interview (1 person) Khana : an umbrella organization belonging to the HIV/AIDS international Alliance

Other: Qualitative assessment about PrEP acceptability

High class and hidden MSM

Individual semi-directive interview (1 person)

Other: Qualitative assessment about PrEP acceptability

Discontinued PrEP user

Individual semi-directive interview (1 person)

Other: Qualitative assessment about PrEP acceptability

Interventions

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-populationsDiscontinued PrEP userFree-lance based entertainment female workers non-using PrEPHealthcare workers in charge of key-populationsHigh class and hidden MSMKey influencer in the EW communityKey influencer in the MSM and/or TGW communityKhanaMale entertainment workersMen who have sex with men (MSM) non-using PrEPMinistry of HealthNCHADSNational Aids AuthorityPrEP usersTransgender women (TGW) non-using PrEPVenue-based entertainment female workers non-using PrEP

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailssee eligibility criteria
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Phnom Penh, Cambodia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHomosexuality

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Vonthanak SAPHONN

    University of Health Sciences (UHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 25, 2021

Study Start

January 1, 2022

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations