ComBaCaL HIV Prevention TwiCs (CoPrev)
Community-based, Village Health Worker-led, eHealth-supported, Integrated HIV Prevention for People at Substantial Risk of HIV Acquisition in Rural Lesotho: Protocol for a Cluster-randomized Hybrid Type 1 effectiveness-implementation Trial Within the ComBaCaL Cohort Study
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).
This study is to evaluate the effectiveness and safety of the CoPrev model in regard to biomedical HIV prevention utilization compared with an enhanced standard of care, in which VHWs assisted by a tablet-based CDS application, perform the same activities except for the prescription and/or delivery of PEP, oral PrEP, COC and self-injectable contraception. Additionally, this study aims to assess the outcomes and processes related to the implementation of such a model.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Approximately 1.3 million new HIV infections were reported worldwide in 2024. Eastern and Southern Africa continue to bear the largest share of the HIV-related burden. To prevent lingering epidemics in these low-resource, high-prevalence regions, it is essential to intensify HIV prevention efforts, including the scale-up of effective biomedical HIV prevention, such as Pre-Exposure (PrEP) and Post- Exposure Prophylaxis (PEP). However, uptake, persistent use and adherence to biomedical HIV prevention remains low among individuals at substantial risk of HIV acquisition, especially in rural areas. Thus, there is an urgent need for scalable, integrated, cost-effective, and context-specific service delivery models that increase the utilization of biomedical HIV prevention among populations at increased risk in Southern Africa.
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).
The ComBaCaL HIV Preven7on (CoPrev) model is a differen7ated, community-based preven7on model, that provides eligible individuals with an alterna7ve to facility-based HIV preven7on and contracep7on. It builds on the broader ComBaCaL model of care, which extends the role of VHWs beyond educa7on, counselling, screening, and referral, to include ac7ve management of preven7on and care services for selected condi7ons. This is enabled through a tablet-based CDS applica7on, allowing VHWs to independently prescribe and deliver selected medica7ons at community level.
Within the CoPrev model, VHWs, assisted by the CDS application, deliver an integrated HIV prevention package comprising HIV prevention education and counselling; HIV and HIV risk screening; condom provision; referral to health facilities, and the prescription and delivery of PEP (TDF/3TC/DTG) and oral PrEP (TDF/3TC) to those eligible. In addition, VHWs provide contraceptive services, including family planning education and counselling; pregnancy screening; referral to health facilities; and the delivery of refills of combined oral contraception (COC) and self-injectable contraception to those eligible.
Typ studie
Fáze
- Nelze použít
Kontakty a umístění
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Participant of the ComBaCaL cohort study (signed informed consent available)
- Weight ≥ 35 kg
- Negative HIV screening test
- No potential exposure to HIV more than 72 hours ago (PEP eligibility window period) and less than 4 weeks ago (window period HIV test)
At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines:
- Report of serodiscordant partner who are not virally suppressed or have an unknown viral suppression status (either not on ART, initiated ART within the last 6 months, known virally unsuppressed or unknown virally suppression status but believed not to be taking treatment regularly)
- Report of sexual partner with unknown HIV status
- Report of unprotected sex with more than one partner in the last 6 months
- Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months
- Report of exchanging money/goods for sex in the last 6 months (as recipient and vice versa)
- Report of intravenous drug use with shared equipment in the last 6 months
- Request for biomedical HIV prevention
Exclusion Criteria:
- Known allergies to PEP/oral PrEP
- Known glomerular filtration rate (GFR) < 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Intervention villages
In the intervention villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study, but in line with the CoPrev model, will also be able to additionally prescribe and deliver drugs for biomedical HIV prevention (PEP (TDF/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg)) and offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c.
104mg/0.65ml
medroxypregosteronacetate).
VHWs will provide monitoring for all dispensed drug regimens, thereby ensuring comprehensive and integrated sexual and reproductive health services within their communities.
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Aktivní komparátor: Control villages
In the control villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study.
Using the tablet-based CDS application, they will be trained and supervised to educate participants on HIV prevention, screen for HIV offering oral HIV self-tests, assess HIV risk behaviour, provide risk reduction counselling and condoms, and refer participants eligible for biomedical HIV prevention to the nearest health facility.
Furthermore, they will offer family planning education, pregnancy screening, and refer participants for contraception.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Monthly biomedical HIV prevention coverage over 6 months after enrolment
Časové okno: Single assessment visit scheduled approximately six months after enrolment (180 days)
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Biomedical HIV prevention coverage is defined at the person- month level as a binary indicator of whether a participant was covered by a biomedical HIV prevention method (PEP (TDF/3TC/DTG), oral PrEP (TDF/3TC), or injectable PrEP) during a given 30-day month within the six-month observation period following enrolment in the ComBaCaL HIV prevention TwiCs .
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Single assessment visit scheduled approximately six months after enrolment (180 days)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Niklaus Labhardt, Division of Clinical Epidemiology, University Hospital Basel
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- Postexpoziční profylaxe (PEP)
- Komunitní zdravotní pracovník (CHW)
- Levonorgestrel (LNG)
- Preexpoziční profylaxe (PrEP)
- Podpora klinického rozhodování (CDS)
- Antiretrovirová terapie (ART)
- Dolutegravir (DTG)
- Komunitní studie zaměřená na chronické onemocnění Lesotho (ComBaCaL).
- Ethinylestradiol (EE)
- Lamivudin (3TC)
- Zkoušky v kohortách (twics)
- Země s nízkými a středními příjmy (LMICs)
- Adolescent girls and young women (AGYW)
- Village health worker (VHW)
- Tenofovir Disoproxil Fumarate (TDF)
- Combined oral contraception (COC)
- Sexually transmitted infection (STI)
Další relevantní podmínky MeSH
- Infekce přenášené krví
- Urogenitální onemocnění
- Onemocnění genitálií
- Patologické procesy
- Atributy nemoci
- Onemocnění imunitního systému
- Infekce
- RNA virové infekce
- Virová onemocnění
- Přenosné nemoci
- Pohlavně přenosné choroby, virové
- Lentivirové infekce
- Retroviridae infekce
- Syndromy imunologické nedostatečnosti
- Pomalá virová onemocnění
- HIV infekce
- Patologické stavy, příznaky a symptomy
- Syndrom získané immunití nedostatečnisti
- Pohlavně přenosné nemoci
Další identifikační čísla studie
- ub26Labhardt2
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