NCT05745168

Brief 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.

Trial Health

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Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jun 2024Oct 2026

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

February 16, 2023

Last Update Submit

January 29, 2024

Conditions

Keywords

Self-testingPrivate pharmacyRDSMSMTransgender women

Outcome Measures

Primary Outcomes (1)

  • Acceptability proportion of HIV self-test by MSM/TGW provided by private pharmacy

    Number of HIV self-tests delivered / total number of coupons distributed

    February 2023 to April 2025

Secondary Outcomes (1)

  • Acceptability and appropriateness provision of HIV self-test to MSM/TGW via private pharmacy

    February 2023 to April 2025

Study Arms (1)

MSM-TGW

Diagnostic Test: OraQuick

Interventions

OraQuickDIAGNOSTIC_TEST

The intervention is based on respondent-driven sampling approach. Each selected seed from hotspots and on social networks is provided with two types of coupons for HIVST kit at partner pharmacy: electronic coupons (e-coupons) consisting of a pictured unique anonymous QR code and identifier and the address of pharmacies; paper coupons consisting of similar information to e-coupon. The seeds will then distribute coupons to their networks physically, via social media, and smart phone applications. Each recruited participant will bring the coupon to be scanned at the pharmacies to receive a free access HIVST kit. There, trained community worker will do the study visit including information/consent, e-CRF filling and providing link to send the test results. These recruited individuals will be considered as wave 1 and will each receive 10 additional coupons to recruit new members in the networks. The next round of individuals recruited and enrolled will be considered as wave 2, and so on.

MSM-TGW

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFor MSM, to have at least one oral or anal intercourse with another man in the past 12 months; For TGW, to be biologically a male at birth and self-identified as a woman or third gender and have at least one oral, anal or vaginal intercourse with another man in the past 12 months
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The survey population consists of MSM and TGW aged from 18 years old who are living in Phnom Penh at the study period regardless of their nationalities or migration history (moving from other provinces)

You may qualify if:

  • To be aged from 18 years old (legal age in Cambodia)
  • For MSM, to have at least one oral or anal intercourse with another man in the past 12 months
  • For TGW, to be biologically a male at birth and self-identified as a woman or third gender and have at least one oral, anal or vaginal intercourse with another man in the past 12 months

You may not qualify if:

  • Known HIV positive status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Phnom Penh, 120210, Cambodia

Location

Related Publications (1)

  • Dary C, Segeral O, Larmarange J, Mosnier E, Ben Mechlia M, Ouk V, Spire B, Saphonn V. Pilot Implementation of HIV Self-Testing Delivery in Private Pharmacies Combined With a Respondent-Driven Sampling Method to Improve HIV Testing for Men Who Have Sex With Men and Transgender Women in Phnom Penh (ANRS 0100s): Protocol for a Prospective Mixed Method Feasibility Study. JMIR Res Protoc. 2025 Jun 27;14:e65351. doi: 10.2196/65351.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Vonthanak Saphonn, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • Mohamed Ben-Mechlia, PhD

    ANRS, Emerging Infectious Diseases

    STUDY DIRECTOR
  • Bruno Spire, PhD

    SESSTIMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chhavarath Dary, PhD

CONTACT

Chhavarath Dary, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

June 1, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations