Randomized Community Trial Community Based Screening for HIV Self Testing in Female Sex Workers in 23 Priority Districts in Indonesia (CBS HIVST in FSW)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,522
- 试验地点
- 2
- 主要终点
- HIV testing uptake
研究概览
简要总结
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.
详细描述
A. Background
- The HIV Epidemic in Indonesia
Until recently, Indonesia was among the few countries in which annual numbers of new HIV infections continued to rise (MoH, 2016). The latest epidemic modeling update indicated that except among men who have sex with man (MSM), annual numbers of new HIV infections had stabilized and begun to decline. However, with the current epidemic trajectory there would still be over 40,000 new HIV infections in the year 2030 (MoH,2016). Therefore, Indonesia is not yet on course to end HIV and AIDS by 2030.
Although there has been a significant increase in the number of persons being treated for HIV/AIDS, the 108,479 people receiving ART as of December 2018 amounts to only 17 percent of the estimated number of people live with HIV (PLHIV) in the country (MoH, 2018). This makes Indonesia a performance "outlier" when compared to countries at comparable levels of gross national income (GNI) and health system development. The lack of more rapid progress has recently led key development partners to question Government of Indonesia (GOI) commitment to meaningfully addressing HIV and AIDS.
Insufficient HIV testing remains a barrier to increasing ART coverage. The number of HIV tests performed annually has risen steadily in recent years, reaching 3,077,653 in calendar year 2018 (MoH, 2018). However, pregnant women account for a sizeable proportion of the increased number of persons being tested. While commendable, the case detection "yield" from testing pregnant women is relatively low. More effective case finding strategies need to be implemented to reach population sub-groups with higher HIV incidence and prevalence, including key affected populations (KAPs) such as female sex workers (FSW). Unless Indonesia can significantly increase its volume and efficiency of HIV testing, it will not be able to reach the first "95" of the UNAIDS 95-95-95 framework - that is, 95% of PLHIV know their HIV status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, 18 years or older at enrollment
- •Reports transactional sex (vaginal, oral and/or anal) at least once in the past month
- •No HIV test in last 6 months
- •Self-reported HIV negative OR HIV status unknown
排除标准
- •Unwilling to participate for any reason
- •Concurrently participating in another HIV prevention study
结局指标
主要结局
HIV testing uptake
时间窗: 7 months
Number of FSWs receiving OFT and facility-based HIV testing, collected from OFT result (Annex 8) and blood test result (Annex 11).
HIV Positivity rate
时间窗: 7 months
Proportion of HIV positive cases among all FSWs who receive facility-based HIV testing (including those who receive post-OFT confirmatory testing), collected through blood test result form (Annex 11).
Antiretroviral (ARV) initiation rate
时间窗: 7 months
Proportion of FSWs with confirmed HIV positivity through facility-based testing (including post-OFT confirmatory tests) who initiate ARV treatment, collected through ARV initiation form (Annex 12).
次要结局
- Client source(at enrollment)
- Age of first sexual transaction(at enrollment)
- Condom use(at enrollment)
- History of sexually transmissible infections (ever been diagnosed with STI by a doctor within the past six months)(at enrollment)
- Education(at enrollment)
- Primary partner(at enrollment)
- History of HIV test(at enrollment)
- Age(at enrollment)
- Marital status(at enrollment)
- Number of clients in the past 7 days(at enrollment)
- History of discomfort during sex or around genitalia within the past six months(at enrollment)
- Stigma score(at enrollment)
- Peer or OW assistance during OFT(immediately after OFT, self-testing)
- Difficulty of OFT use(immediately after OFT, self-testing)
- Certainty of result(immediately after OFT, self-testing)
- OFT result(immediately after OFT, self-testing)
- Previous knowledge of OFT(at enrollment)
- Willingness to receive routine testing after OFT (only for negative OFT)(immediately after OFT, self-testing)
- Experience of testing(immediately after OFT, self-testing)
- Difficulty of interpreting OFT results(immediately after OFT, self-testing)
- Clarity of OFT instructions(immediately after OFT, self-testing)
- Perceived support (only for assisted OFT)(immediately after OFT, self-testing)
- Desire to recommend OFT testing to peers(immediately after OFT, self-testing)
- Desire to confirm OFT result(immediately after OFT, self-testing)
研究者
dr. Pande Putu Januraga, DrPH
Principal Investigator
Kerti Praja Foundation
