Csak meghívásos2. fázis

Peer Delivered HIV/Syphilis Self-Testing With Assisted Partner Notification Services

A legfontosabb adatok

Ki végzi: Makerere University
Hol: Wakiso (Uganda)A helyszín megnézése
Azonosító: NCT06791928
Állapot: Csak meghívásos
Fázis: 2. fázis
Résztvevők: 200 fő, tervezett
Kezdés: 2024. aug. 25.
Várható befejezés: 2028. dec. 1.
A vizsgálat típusa: Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések: Peer distribution of self testking kits
A regiszteradat frissítve: 2025. január 24.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat 18 éves vagy idősebb, férfiakkal szexuális kapcsolatot tartó férfiakat keres. Az elmúlt három hónapban nem lehettek HIV- vagy szifilisztesztelésen.

Életkor: 18–65 év
Nem: Csak férfiak
Korábbi kezelés: Aki szifilisz miatt kezelés alatt áll, nem csatlakozhat.
Biomarker vagy leletérték: Az elmúlt három hónapban nem volt HIV- vagy szifilisztesztelésen, vagy még soha nem tesztelték.

A részvétel fő kizáró okai

Már tudja, hogy HIV-pozitív
Szifilisz miatt kezelés alatt áll
Másik HIV-megelőzési vizsgálatban részt vesz
Nem beszél angolul és luganda nyelven

A regiszter feltételei, szó szerint

Mind a 9 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

18 és 65 év között vagy?

Helyszínek itt: Uganda

Infectious Diseases Institute, Makerere UniversityWakiso, UgandaNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

Intervention armA vizsgált kezelés
a) deliver HIVST/syphilis self-testing kits to MSM within their networks using SNS and target never or infrequent testers; b) actively link MSM who test positive to confirmatory testing and care; c) offer sexual partners voluntary assisted partner notification and HIV/syphilis testing while maintaining confidentiality
Kezelés: Peer distribution of self testking kits
Control armMár használt kezelés, összehasonlításként
a) distribute invitation letters to social network members for fast-track HIV/syphilis testing at a health facility. All MSM will receive: i) free confirmatory HIV and syphilis testing, condoms, and treatment and ii) psychosocial peer support at the health facility.
Kezelés: Peer distribution of self testking kits