HivANRS 12415NCT05091489
ANRS 12415 - Quali PrEP Cambodia
An observational study of Hiv, run by Institut de Recherche pour le Developpement at 1 site in Cambodia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Qualitative assessment about PrEP acceptability
- How many people
- 88 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Jan 2022to 15 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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
- Conditions
- Hiv
- Being tested
- Qualitative assessment about PrEP acceptability
- Keywords
- Men who have sex with men (MSM), Transgender women (TGW), Sex workers, Healthcare, Community-based organisations, PrEP, Pre-exposition prophylaxis, focus group, interview, Cambodia, qualitative, acceptability, prevention, men who have sex with men, decision makers, community workers
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative assessment about PrEP acceptabilityOther
Qualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews
| Study group | Role | What they receive |
|---|---|---|
| Men who have sex with men (MSM) non-using PrEP | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Male entertainment workers | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Free-lance based entertainment female workers non-using PrEP | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Venue-based entertainment female workers non-using PrEP | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Transgender women (TGW) non-using PrEP | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Healthcare workers in charge of key-populations | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Community workers in charge of key-populations | Focus group (10 persons) Receives: Other: Qualitative assessment about PrEP acceptability | |
| PrEP users | Focus group (10 persons) Receives: 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) Receives: 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) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Ministry of Health | Individual semi-directive interview (1 person) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Key influencer in the MSM and/or TGW community | Individual semi-directive interview (1 person) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Key influencer in the EW community | Individual semi-directive interview (1 person) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Khana | Individual semi-directive interview (1 person)
Khana : an umbrella organization belonging to the HIV/AIDS international Alliance Receives: Other: Qualitative assessment about PrEP acceptability | |
| High class and hidden MSM | Individual semi-directive interview (1 person) Receives: Other: Qualitative assessment about PrEP acceptability | |
| Discontinued PrEP user | Individual semi-directive interview (1 person) Receives: Other: Qualitative assessment about PrEP acceptability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about PrEP
qualitative assessement
Measured: 1 hour
Perception of PrEP
qualitative assessement
Measured: 1 hour
Acceptability of PrEP
qualitative assessement
Measured: 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
qualitative assessement
Measured: 1 hour
To identify tools that could be useful to increase PrEP awareness and acceptability, especially new technologies (apps, websites)
qualitative assessement
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jan 2022
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- University of Health Sciences, Phnom Penh, Cambodia, National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia
- Responsible party
- Principal investigator, Marion Fiorentino, Institut de Recherche pour le Developpement
- Investigators
- Vonthanak SAPHONN, Principal investigator, University of Health Sciences (UHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091489
- Sponsor's protocol ID
- PREP2021-MF
- Acronym
- ANRS 12415
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Assessment About PrEP Acceptability in Key-populations and Conditions Required for Community-based PrEP Implementation in Cambodia
- ClinicalTrials.gov ID
- NCT05091489
- Acronym / sponsor ID
- ANRS 12415 / PREP2021-MF
- Conditions
- Hiv
- Keywords
- Men who have sex with men (MSM), Transgender women (TGW), Sex workers, Healthcare, Community-based organisations, PrEP, Pre-exposition prophylaxis, focus group
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- University of Health Sciences, Phnom Penh, Cambodia, National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Men who have sex with men (MSM) non-using PrEP | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| Male entertainment workers | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| Free-lance based entertainment female workers non-using PrEP | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| Venue-based entertainment female workers non-using PrEP | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| Transgender women (TGW) non-using PrEP | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| Healthcare workers in charge of key-populations | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| Community workers in charge of key-populations | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| PrEP users | – | Other: Qualitative assessment about PrEP acceptabilityFocus group (10 persons) |
| NCHADS | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) (NCHADS: operational unit of the Ministry of Health in charge of health sector policy development for HIV/AIDS) |
| National Aids Authority | – | Other: Qualitative assessment about PrEP acceptabilityIndividual 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) |
| Ministry of Health | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) |
| Key influencer in the MSM and/or TGW community | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) |
| Key influencer in the EW community | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) |
| Khana | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) Khana : an umbrella organization belonging to the HIV/AIDS international Alliance |
| High class and hidden MSM | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) |
| Discontinued PrEP user | – | Other: Qualitative assessment about PrEP acceptabilityIndividual semi-directive interview (1 person) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative assessment about PrEP acceptabilityQualitative research among key-populations, community and healthcare workers, and decision and policy makers, including focus group and semi-directive interviews | Other | Community workers in charge of key-populations, Discontinued PrEP user, Free-lance based entertainment female workers non-using PrEP, Healthcare workers in charge of key-populations, High class and hidden MSM, Key influencer in the EW community, Key influencer in the MSM and/or TGW community, Khana, Male entertainment workers, Men who have sex with men (MSM) non-using PrEP, Ministry of Health, NCHADS, National Aids Authority, PrEP users, Transgender women (TGW) non-using PrEP, Venue-based entertainment female workers non-using PrEP |
Primary outcome
Knowledge about PrEP
Time frame: 1 hour
qualitative assessement
Perception of PrEP
Time frame: 1 hour
qualitative assessement
Acceptability of PrEP
Time frame: 1 hour
qualitative assessement
2 secondary outcomes
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
To identify tools that could be useful to increase PrEP awareness and acceptability, especially new technologies (apps, websites)
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vonthanak SAPHONN principal investigator
University of Health Sciences (UHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by Institut de Recherche pour le Developpement at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about PrEP (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.