Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05745168 |
| Other study ID # |
ANRS0100s |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
October 2026 |
Study information
| Verified date |
January 2024 |
| Source |
ANRS, Emerging Infectious Diseases |
| Contact |
Chhavarath Dary, PhD |
| Phone |
85517676953 |
| Email |
dr_chhavarath[@]uhs.edu.kh |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study aims to evaluate the feasibility of HIV self-testing (HIVST) delivery by a private
pharmacy network among men who have sex with men (MSM) and transgender women (TGW) recruited
through a classic and digital Respondent Driven Sampling method to improve HIV testing in
Phnom Penh, Cambodia.
An interventional pilot study using a mixed qualitative and quantitative approach will be
carried out in order to evaluate the feasibility, acceptability and appropriateness of the
strategy and to identify barriers and facilitators.
Description:
INTRODUCTION AND OBJECTIVES
The last Cambodian 2019 IBBS report highlighted the fact that half of men who have sex with
men (MSM) and one third of transgender women (TGW) were never tested for HIV or since more
than 12 months. Receiving HIV education and materials in the past 6 months and perception of
higher HIV risk compared to the general population were the common factors associated with
the increasing HIV testing uptake. In this report, the majority of MSM and TGW were tested at
Community-based organizations (CBO) facilities and by CBO outreach workers while private
facilities are poorly used for HIV testing (5% for MSM and 2% for TGW). Private pharmacies
could be able to deliver HIV selftesting (HIVST) kits giving the advantage of
confidentiality, anonymity and time-saving, in particular for those reluctant to visit CBOs
by lack of secrecy regarding their sexual orientation.The recruitment of participants by RDS
could give the opportunity to reach MSM and TGW outside the network of CBOs.
The principal objective is to evaluate the feasibility of HIV self-testing (HIVST) delivery
by a private pharmacy network among men who have sex with men (MSM) and transgender women
(TGW) recruited through a classic and digital Respondent Driven Sampling method to improve
HIV testing in Phnom Penh, Cambodia
Our secondary objectives are:
- Evaluate the acceptability and appropriateness of the strategy
- Identify barriers and facilitators
- Estimate the linkage to confirmatory testing for those with a reactive test and linkage
to HIV care and ART for those with a positive confirmatory HIV test
- Estimate linkage to pre-exposure prophylaxis (PrEP) services for negative participants
- Estimate the characteristics of participants and compare to those reported in Integrated
Biological and Behavioral Survey (IBBS 2019) for MSM and TGW in Cambodia
- Evaluate the adherence of participants to a 6-monthly repeated HIV testing
METHODOLOGY
Study design An interventional pilot study using a mixed qualitative and quantitative
approach will be carried out in order to evaluate the feasibility, acceptability and
appropriateness of the strategy and to identify barriers and facilitators.
The participant recruitment method will be designed as a Respondent Driven Sampling (RDS) by
recruiting initial seeds both at hotspots and on social networks.
After 6 months, a qualitative assessment by focus groups discussion (FGD) will be conducted
among MSM, TGW and pharmacists to evaluate feasibility, acceptability and appropriateness of
the intervention and to identify barriers and facilitators.
Each participant will be followed during 18 months and encouraged to perform a 6-monthly HIV
testing during this period.
Study overview
The intervention will be designed as a RDS by recruiting initial seeds both at hotspots and
on social networks. 15 initial seeds will be recruited. Seeds will come to the study site for
checking inclusion criteria and receiving information on self-testing, benefits of their
participation and recruiting other participants in their networks along with the important
details about the study. Once consent to the study, the seed is provided with two types of
coupons for HIVST kit at partner pharmacy: 5 electronic coupons (e-coupons) consisting of a
pictured unique anonymous QR code and identifier and address of partner pharmacies; 5 paper
coupons consisting of a printed unique anonymous QR code, identifier and address of partner
pharmacies. The seeds will then distribute electronic and paper coupons to their networks
physically and via social media, messaging and calling applications such as Twitter, Whatapp
and Telegram (e-coupons).
Each recruited participant will bring the coupon to be scanned at partner pharmacies to
receive direct and free access to one HIVST kit. Partner pharmacies with a proper dedicated
room/space securing privacy and secrecy in Phnom Penh are the study sites. There, trained
community worker/research team who get notified by partner at each visit of participant will
do the study visit including information/consent, e-CRF filling and give a link of an
external website to send the HIV test results and receive information or advices.
These recruited individuals will be considered as wave 1 of recruitment and will each receive
10 additional coupons to recruit the members of their networks. The next round of individuals
recruited and enrolled will be considered as wave 2, and so on. The number of 10 coupons was
selected to avoid a bias risk related to participation incentives.
To facilitate the return of HIVST kit results, participant will upload the picture of results
labeled with their identifier directly using the link of the external website that they
received from community worker/research team during their visits at pharmacy. In case of any
question, they could reach community worker/research team by hotline number. According to the
results, the participants will be proposed with a support for linkage to confirmatory test or
to PrEP services. Each non-reactive participant will be provided another new coupon (paper or
electronic format upon their preference) with a reminder to perform a 6-monthly HIV testing
during 18 months. They will not be granted any token or incentives if they fail to return the
result of HIVST kit taken at pharmacies.
After 6 months, a qualitative assessment will be conducted to evaluate feasibility,
acceptability and appropriateness of the intervention and to identify barriers and
facilitators.
Several ART sites/HIV clinics particularly in charge of key populations will be specifically
selected as participating centers in order to collect information on linkage to care or
prevention services for positive and negative participants, respectively.
Statistical methods
To evaluate the feasibility of the intervention to improve HIV testing among MSM and TGW in
Phnom Penh, a pragmatic approach with the objective to recruit the maximum of MSM and TGW was
carried out. According to the IBBS 2019, the estimated number of MSM in Phnom Penh is 6300
and the estimated number of TGW is 1400.
With 1500 participants (1000 MSM and 500 TGW), the proportion of an HIV self-test uptake was
estimated to be 70% to within a 95% confidence interval of +/- 2 - 2.5% (width of the
confidence interval (in %) = 1.96 x √( p x (1-p) / n)). Intervention
RDS intervention
The seeds will be recruited at hotspots, online applications and social media networks.
Hotspots include steam sauna and spa and gay bars and clubs. Online applications and social
media include Facebook groups, twitter, telegram, whatapps and other date applications such
as Grindr, Planet Romeo, Hornet, Blued.
Prior to seed recruitment, a consultative meeting will be conducted among pimps (a person who
controls sex workers, especially by finding customers for them, and takes some of the money
that they earn), procurers (a person who finds sex workers for people who want to have sex
with them), high class MSM & TGW, network organizers, social media group organizers in order
to optimize the selection criteria of the seeds.
Selection criteria obtained from the meeting with pimps, procurers, high class MSM, network
organizers, twitter groups organizer is applied to select the initial seeds that are very
likely to lead us to reach a large diversity of MSM&TGW population.
A number of 15 seeds will be selected firstly to ensure the representation of gender, age
group, sexual behaviors, and participation in sex work. If necessary, new seeds could be
recruited later. Seeds will come to the study site for checking inclusion criteria and
receiving information on self-testing, benefits of their participation and recruiting other
participants in their networks along with the important details about the study. Once consent
to the study, the seed is provided with two types of coupons for HIVST kit at partner
pharmacy: 1- 5 electronic coupons (e-coupons) consisting of a pictured unique anonymous QR
code and identifier and address of partner pharmacies 2- 5 paper coupons consisting of a
printed unique anonymous QR code, identifier and address of partner pharmacies. The seeds
will provide paper- and e-coupons to their networks physically and via social media,
messaging and calling applications such as Twitter, Whatapp and Telegram (e-coupons). For
online application and social media, a peer could be reached by chat or call.
When the participant arrives in a partner pharmacy, the coupon (unique QR code with
identifier) will be scanned by the pharmacist prior to the free delivery of HIV self-test.
Community workers (CWs) will be then alerted by the pharmacist for study visits to
participant directly at the dedicated space at the pharmacy. During the visit with CW,
participant will receive the information about the study, check for eligibility criteria, ask
to be recontacted by phone and participation in FGD, fill in the detailed e-CRF, receive the
information on HIV self-testing instructions, list of partner pharmacies, helpline phone
number, location of the 2 partners ART sites, location of the HIV clinics with prevention
services and PrEP delivery availability, be provided one free HIV self-testing kit delivered
Incentives will be provided in two steps for participants to encourage them to return the
results of HIVST and recruit their peers. In step one, each participant will receive 2 USD
for returning the HIVST result successfully to the provided link. In step two, an amount of 1
USD will be provided for each recruited peer. This amount was decided as a balance between
feasibility (encouragement) and sustainability of the strategy (not too high for possible
scaling-up).
In case of any issue for tablet use or HIVST kit use, helpline phone number will be
available. One dedicated community worker funded by the study will be in charge to manage
helpline service.
Intervention after delivering HIV test result
In case of reactive HIV test, the participant could join immediately one research team by
hotline or messages on the website that will provide support and orientation. After 1 week,
contact with the participant will be done by phone by the research team (if the participant
gave consent) to confirm the linkage to one of the partner ART sites. The linkage between
participants and HIV clinics will be done by the initial QR code.
If the linkage to confirmatory testing and/or care is not confirmed, a community worker
provides additional assistance to the participants.
In case of non-reactive test, the participant could download in the external website one
electronic coupon (QR code) to repeat the HIV test 6 month later. Participants will be
informed on the external website about the possibilities to join the pilot PrEP program in
Chhouk Sar clinic in Phnom Penh.
Qualitative assessment
After 6 months, a qualitative assessment will be conducted to evaluate acceptability and
appropriateness of the intervention. Qualitative assessment will be done by focus groups.
Focus groups will be conducted in 3 specific populations: MSM, TGW and pharmacists. For each
population of MSM and TGW, a qualitative sample will be selected in order to capture
different profiles according to sex behaviors and demographic and socioeconomic
characteristics.
