跳至主要内容
临床试验/NCT06791928
NCT06791928Enrolling By Invitation2 期

Peer Delivered HIV/Syphilis Self-Testing with Assisted Partner Notification Services for Men Who Have Sex with Men (MSM) in Uganda

Makerere University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月25日最近更新:
适应症

试验速览

阶段
2 期
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Intervention acceptability

研究概览

简要总结

Background and rationale Men who engage in sexual relations with other men (MSM) are disproportionately affected by HIV and other sexually transmitted infections (STI), such as syphilis. Globally, MSM have a 28 times greater risk of HIV acquisition than adult men (15-49 years) in the general population. In Uganda, HIV prevalence in MSM is 13.2% versus 4.7% in similarly aged heterosexual males, while syphilis prevalence is 8.3% versus 5.8% in males aged 15-64 years. Syphilis and HIV transmission share common sexual risk behaviors, and syphilis increases HIV acquisition risk three-fold. Uganda guidelines recommend annual HIV/syphilis testing for MSM, but uptake of facility-based HIV testing is low (32%) of the estimated MSM population in Kampala. Assisted partner notification (services, i.e., tracing sexual partners of people with HIV and offering them testing services, is the standard of care (SOC) in Uganda. The World Health Organization recommends task shifting to MSM peers to increase access to and availability of HIV/syphilis testing services. Differentiated service delivery models, such as peer-delivered HIV/syphilis self-tests and assisted partner notification with linkage to care, could improve engagement in care by MSM. Our prior work found that peer-delivery of HIV self-tests (HIVST) was feasible and acceptable to 90% of MSM in Uganda. All those newly diagnosed with HIV received confirmatory testing, were linked to care, and started antiretroviral treatment (ART). Other work in Zimbabwe found high acceptability (89.6%) of peer-delivered syphilis self-tests among MSM. Joint delivery of peer-delivered HIV/syphilis self-tests and assisted partner notification is an empowering, innovative approach that could substantially increase testing among MSM in Uganda and help achieve global HIV 95:95:95 targets. However, no studies to our knowledge have evaluated the effectiveness of peer-delivered HIV/syphilis self-tests and assisted partner notification services for MSM in any setting.

Study objectives

  1. To assess the feasibility and acceptability of implementation of peer-delivered self-tests for HIV and syphilis with partner services for Ugandan MSM.
  2. To assess the preliminary effectiveness of peer-delivered HIV/syphilis self-tests and partner services versus facility-based testing.
  3. To estimate the cost-effectiveness of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing.

Study design Objective 1: Cross-sectional qualitative study design (formative stage). Objective 2: Cluster randomized trial to pilot test the preliminary effectiveness of peer-delivered HIV/syphilis self-tests and partner services versus facility-based testing.

Objective 3: Cost-effectiveness analysis using payers and health sector perspectives.

Primary outcomes for objective 2:

  1. Adoption (proportion reached using self-tests and assisted partner notification.
  2. Linkage (proportion of testers linked to services)
  3. Intervention acceptability (assessed using 5-point Likert scales)
  4. Fidelity (assessed through 20 field observations checklist of peer activities (10 per arm).

Data analysis Objective 1: Investigators will use content analysis techniques. Two coders will read a random subset of interviews to identify general themes and create a preliminary codebook. A subset of transcripts will be coded together, and findings will be discussed to resolve discrepancies. An additional subset of interviews will be coded using the revised codebook, and Cohen's kappa will be calculated. Themes with kappa values of <0.60 will be redefined.

Objective 2: Sociodemographic characteristics will be summarized using descriptive statistics. The primary outcomes shall be analyzed using intent-to-treat. All participants who receive an HIV/syphilis test will be included in the analysis. Those who receive the self-test kits but do not use them will also be included in intent-to-treat analyses to provide the most generalizable effect measure. Mixed effects/multi-level models using modified Poisson regression with robust standard errors will be used to estimate relative risks of HIV/syphilis testing (yes/no). They permit estimation of relative risks with more stability than log binomial or logistic models. The random effects from mixed effects/multi-level model appropriately adjust for correlation in outcomes within participants and between participants recruited by the same peer (i.e., clustering effect).

Objective 3: Cost-effectiveness analysis of peer-delivered HIV/syphilis self-tests and partner services compared to facility-based testing. Cost-effectiveness will be estimated as cost per additional person reached and cost per additional person linked from the healthcare sector and client perspectives.

详细描述

Men who engage in sexual relations with other men (MSM)(1) are disproportionately affected by HIV and syphilis. Globally, gay men and other men who have sex with men have 28 times greater risk of HIV acquisition than adult men (15-49 years) in the general population.(2). Syphilis and HIV disproportionately affect MSM because of sexual network dynamics that include high-risk sexual practices and multiple sex partners.(3,4). HIV and syphilis co-infection is common because syphilis and HIV have similar modes of transmission(5,6). Having syphilis is associated with a 3-fold increased risk of HIV acquisition.(7,8); syphilis also increases the risk of HIV transmission and disease progression(9). The resurgence of syphilis among MSM globally(10,11) is attributed to increasing rates of risky sexual behaviors, such as anonymous sex, oral and anal condomless sex, sex with multiple partners, and/or sex under the influence of drugs(5,12). In 2013, the United States estimated that 46% of MSM with primary and secondary syphilis had HIV, compared to 8% of heterosexual men and 6% of women.(6). In sub-Saharan Africa, 6% of new HIV infections occurred among MSM in 2021(13). In Uganda, HIV prevalence among MSM was 13.2% in 2012 compared to 4.7% in similarly-aged males. (14,15).. Of the 41,655 syphilis cases reported in the United States in 2020, 43% were among MSM(16). In 2016, syphilis prevalence among MSM in Uganda was estimated at 9.0%(17) compared with 5.8% in males aged 15-64 years(14,15). Ugandan national 2020 guidelines for HIV prevention and care recommend annual STI testing as a strategy for STI prevention among MSM and their sexual networks, but uptake of facility-based STI testing is low (32%) of the estimated MSM population in Kampala. (14,15) ,(18). To achieve the WHO Global Health Sector Strategy goal of reducing syphilis incidence by 90% by 2030(19), and the first UNAIDS 95-95-95 goal of 95% of persons with HIV knowing their status by 2025(20), scaling up HIV/syphilis testing is critical to reaching undiagnosed MSM.

1.2. HIV/syphilis testing is the entry point to treatment and prevention services The World Health Organization (WHO) recommends dual HIV/syphilis testing for MSM.(21). Increasing testing coverage is key to reaching the first UNAIDS 95-95-95 target and reducing disease incidence.(13,20). Early detection, timely linkage to care and other prevention services, and identification of sexual contacts reduced HIV transmission by 89% among MSM in Bangkok.(22). However, current testing strategies in sub-Saharan Africa only reach men who are not at high risk of HIV and/or already tested for HIV and are thus low yield: 2.4% HIV positivity for provider-initiated testing, 2.9% positivity for voluntary counseling and testing, and 3.1% positivity for mobile testing approaches.(7). Thus, identifying high-yield strategies for dual HIV/syphilis testing that effectively reach MSM in the riskiest sexual networks is key.(23). In Uganda, HIV/syphilis testing uptake is still low among MSM despite efforts to scale up prevention services for this population.(23). A recent bio-behavioral survey in 2020 estimated that there were 202,343 undiagnosed HIV infections in Uganda, of which 44% were in men, mostly MSM and their sexual contacts.(24). Data on syphilis test uptake and coverage among MSM in Uganda are lacking.(15). In contrast, syphilis test coverage among pregnant women attending antenatal clinics is >80%(25). This high coverage is part of a comprehensive dual HIV/syphilis elimination strategy using the SD BIOLINE HIV/syphilis Duo assay.(26,27). This assay is available at health facilities that are not friendly to MSM because of stigma and discrimination. Decentralized testing and community-based approaches could improve dual HIV/syphilis test uptake in this population.

1.3. Self-testing is feasible and acceptable to MSM Self-administered HIV self-tests (HIVST) and syphilis self-tests (permit the user to interpret test results by themselves in private (28). A scoping review of 11 studies in sub-Saharan Africa found that HIVST was feasible and acceptable to MSM (29). Studies among MSM in China(30,31) have shown that syphilis self-testing may increase testing frequency by empowering MSM to test and reducing the impact of structural barriers(32), but data from sub-Saharan Africa are limited. Combining HIVST and syphilis self-testing with peer delivery offers a unique opportunity to reach MSM with user-friendly technology in their communities. This strategy could overcome some of the barriers associated with facility-based testing, and promote early diagnosis and linkage to prevention services. As demonstrated with at-home COVID-19 testing, HIV and syphilis self-testing could sustain testing services when health facilities are inaccessible or inconvenient(33).

1.4. Peer-delivered self-tests can efficiently reach MSM and their social networks Peer approaches are recommended by the WHO for HIV testing.(30,34) and can be leveraged for dual HIV/syphilis testing. Peer delivery is a person-centered approach that could maximize the coverage, effectiveness, efficiency, and impact of HIV/syphilis services for MSM in Uganda. Peers are non-clinically trained persons with similar background characteristics to the beneficiary population. (34). Peer-led outreach services reach more MSM than traditional approaches by generating demand in the community and tapping into MSM social networks.(35,36). In Zimbabwe, peer-delivered syphilis self-testing was highly acceptable (89.6%), increased privacy, convenience, and autonomy, and helped circumvent social and healthcare provider stigma.(37). Our prior work found that peer-delivery of HIV self-tests was acceptable to 90% of MSM in Uganda.(38,39). All newly diagnosed participants with HIV infection were linked successfully to receive confirmatory testing at a friendly health facility and linked to treatment using a peer-assisted linkage model.(38). Thus, HIVST and syphilis self-testing linked with partner services may empower MSM and expand testing uptake and coverage.(1).

1.5. Integrating assisted partner notification with peer-led self-testing approaches could accelerate prevention uptake among MSM Assisted partner notification is an evidence-based strategy in which a trained provider encourages persons with an HIV/STI diagnosis to disclose their status to their sexual partners. Assisted partner notification is recommended by WHO, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), and the Uganda Ministry of Health and offers testing services to sexual partners of index cases with their consent(40,41). Assisted partner notification is acceptable and feasible(42-45) and increases testing uptake among sexual partners(42,45,46), enables early diagnosis, and linkage to care and other prevention services, motivates behavior change in index cases and partners, and may reduce STI and HIV burden(42-45). A pilot partner services program in rural Uganda that enrolled 464 people with HIV (PWH) and tested their recent sexual partners found that 32% (61/193) of sexual partners who were traced and tested had HIV(46). A mathematical modeling study in South Africa found that assisted partner notification could enable the identification of new HIV diagnoses among MSM(47). Similarly, a combination of assisted partner notification, HIVST, and community worker outreach was acceptable and feasible in Kenya(48) and increased uptake of HIV testing and linkage to care and PrEP among MSM and their sexual partners(48,49). A systematic review of 26 trials found that assisted partner notification identified more undiagnosed syphilis cases than passive notification(50). Thus, partner services could efficiently identify MSM with undiagnosed HIV and syphilis and help reach the first UNAIDS 95 target and global syphilis elimination goals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • In both arms, peers will recruit network members who are
  • aged 18 years and older,
  • Self-report of anal sexual intercourse at least once in the prior quarter
  • self-identify as MSM,
  • not tested in the past three months or never tested for HIV or syphilis before;
  • willing to provide informed consent;
  • willing to undergo study procedures

排除标准

  • We will exclude participants
  • Participants who already know that they have HIV and those who are on treatment for syphilis
  • Those enrolled in other HIV prevention trial
  • We shall exclude participants who don't speak English and Luganda

结局指标

主要结局

Intervention acceptability

时间窗: 12 months

This will be measured as uptake of HIVST and syphilis self-testing kits between the two arms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验