Community Based Screening for HIV Self Testing in FSW in 23 Priority Districts in Indonesia

NCT04578145 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1522

Last updated 2020-10-08

No results posted yet for this study

Summary

Indonesia is not yet on course to end HIV and AIDS by 2030. Epidemic transmission of HIV infection among key affected populations (KAPs), specifically FSWs, crucially has contributed to not achieving the target. Although the number of HIV tests performed annually has grown steadily in recent years, reaching 3,077,653 in calendar year 2018, pregnant women is accounted for a fairly large proportion of an increased number of persons being tested (MoH, 2018).

Regarding the FSWs, it has been a significant challenge to increase HIV testing uptake among this population. The challenge has been affected by Indonesia's national policy to close brothels. As consequence, many FSWs have become hidden and hard to reach. The implementation national policy also impacts on the way of commercial sex transactions in which it becomes underground, especially many FSWs utilize the new popularity of digital platforms to sell sexual services. It needs more effective case finding strategies to be implemented to reach them accordingly.

If it is considered from the FSWs side, there are some barriers to access HIV test services according to several reports. They consist of lack of money, time, stigma, discrimination, low-risk perception, fear, lack of accessibility, reluctance of health service providers to offer HIV testing and limited human resources. Oral fluid HIVST using is an alternative to traditional HIV testing services in the facility or other healthcare provider testing (UNAIDS, 2016). For this study, OraQuick is used as an alternative strategy for HIV testing among FSWs.

The primary objectives of this study are to assess whether proportion of FSW, who know their HIV status, increases or not; whether introduction of Oral fluid test increases the number of HIV testing at health facilities or not; and whether "assisted" or "unassisted" community HIV screening have a result to an increasing proportion of HIV testing at health facilities or not. Furthermore, CBS study aims to assess whether "assisted" and "unassisted" community HIV screening results to an increasing number of HIV positive case finding or not; and whether community HIV screening increases proportion of initiation of antiretroviral therapy (ART) or not. The secondary objectives of this study, meanwhile, are to measure acceptability of community-based self-screening in participation and to measure satisfaction of FSWs, who has participated, towards the delivery of community-based self-screening.

Regarding the inclusion criteria of this study, participant must be women 18 years old or older at enrollment; has a transactional sex (vaginal, oral and/or anal) at least once in the past month; does not uptake HIV test in the last 6 months; and acknowledges her HIV status 'negative' or 'unknown'. There are several exclusion criteria, which are FSW does not able to fulfill one of inclusion criteria that has been explained above; FSW does not has desire to participate due to several reasons; and she is currently participating in another HIV prevention study.

Outcome variables of this study are to compare the characteristic FSWs who receive self-testing and blood testing; who receive assisted and unassisted self-testing. Moreover, it compares the proportion of taking confirmatory test out of those who receive the test in the assisted and unassisted self-testing; proportion of FSWs who receive HIV test out of those who got offered for the test (including self-testing) in the intervention group with proportion of FSWs who receive HIV test in the control group; the proportion of FSWs taking confirmatory test (including self-testing) out of those receive the test in intervention groups and control group. It compares, furthermore, the proportion of HIV positive in the assisted, unassisted (intervention) and HIV positive in the control group. This study also compares ART initiation in the assisted, unassisted (intervention) and the control group. Additionally, it compares stigma scores and FSWs who went to a health facility for HIV testing between assisted, unassisted group and compares the HIV and STI risk behaviors between assisted and unassisted group. It calculates, lastly, the cascade of HIV testing and treatment.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DIAGNOSTIC_TEST

HIV self-testing among female sex workers

Barriers faced by FSWs in terms of undergoing HIV blood test seemingly overcome through the implementation of alternative strategy of testing, by using OFT self-testing (Ora-Quick). Ora-Quick test used in this study measures antibody in oral fluid of participants. The oral fluid is collected used a test swab from participant's gum by wiping upper and lower gums once. The specimen mixed with buffered developer solution in test tube. Test result will appear in a short time, by 20 to 40 minutes and leading to interpret.

Sponsors & Collaborators

  • United Nations

    collaborator OTHER
  • Kerti Praja Foundation

    lead OTHER

Principal Investigators

  • Anak Agung Sagung Sawitri, DR · Kerti Praja Foundation

  • I G. A. A Mahendra, MPH · Kerti Praja Foundation

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04578145 on ClinicalTrials.gov