- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02556957
CHWs, mHealth, and Combination HIV Prevention (mLAKE)
CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field.
The investigators propose an implementation science, cluster-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support and counseling tools to promote CHP along this entire continuum of HIV service utilization. The hypotheses for this implementation science research are that residents in clusters receiving the implementation intervention will have improved CHP service uptake and decreased Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.
The intervention will be evaluated through a pragmatic, cluster-randomized trial nested within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort Study (RCCS). Intervention arm participants will be visited in their place of residence by CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP health counseling, linkage, and adherence support, all supported by a mHealth decision support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will be HIV incidence, population viral load, implementation measures, retention, virologic suppression, and sexual behaviors.
Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will be prospectively measured to provide information on program affordability.
Through this study, a novel, low-cost, and scalable implementation intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Entebee, Uganda
- Rakai Health Sciences Program
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Resident of Kasensero
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: HealthScouts Intervention
HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application.
|
|
Aktiv komparator: Standard of Care
Referral by RCCS to HIV services.
Free HIV clinic available in the community.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Population Prevalence of Detectable Viremia
Tidsramme: 4 Years
|
Proportion of the entire population who have detectable HIV viremia
|
4 Years
|
ART Coverage (self-report)
Tidsramme: 4 Years
|
Proportion of HIV+ persons who are on ART
|
4 Years
|
HIV Care Coverage (self-report)
Tidsramme: 4 years
|
Proportion of HIV+ persons who are in HIV care
|
4 years
|
Medical Male Circumcision Coverage (self-report)
Tidsramme: 4 years.
|
Proportion of men who are circumcised
|
4 years.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HIV Incidence
Tidsramme: 4 years.
|
4 years.
|
|
Sexual Behaviors (self-report)
Tidsramme: 4 years
|
Proportion of the population which has multiple partners and/or inconsistent or no condom use
|
4 years
|
Population HIV Viral Load
Tidsramme: 4 years
|
The mean viral load of HIV+ persons
|
4 years
|
HIV Counseling and Testing Coverage (self-report)
Tidsramme: 4 years
|
Proportion of the entire population who have received HIV Counseling and Testing
|
4 years
|
HIV Prevalence
Tidsramme: 4 years
|
The prevalence of HIV in the entire population
|
4 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Larry W Chang, Johns Hopkins School of Medicine
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Chang LW, Mbabali I, Hutton H, Amico KR, Kong X, Mulamba J, Anok A, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, Pollard R, van Wickle K, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray RH, Wawer MJ, Nakigozi G. Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial. PLoS Med. 2021 Jan 6;18(1):e1003475. doi: 10.1371/journal.pmed.1003475. eCollection 2021 Jan.
- Chang LW, Mbabali I, Kong X, Hutton H, Amico KR, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray R, Wawer M, Nakigozi G. Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):494. doi: 10.1186/s13063-017-2243-6.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB00062089
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrutteringHIV | HIV-testing | HIV-kobling til omsorg | HIV-behandlingForente stater
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationFullførtPartner HIV-testing | Par HIV-rådgivning | Parkommunikasjon | HIV-forekomstKamerun, Den dominikanske republikk, Georgia, India
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement og andre samarbeidspartnereUkjentHIV | HIV-uinfiserte barn | Barn utsatt for HIVKamerun
-
University of MinnesotaTilbaketrukketHIV-infeksjoner | HIV/AIDS | Hiv | AIDS | Aids/Hiv problem | AIDS og infeksjonerForente stater
-
Erasmus Medical CenterHar ikke rekruttert ennåHIV-infeksjoner | Hiv | HIV-1-infeksjon | HIV I infeksjonNederland
-
Hospital Clinic of BarcelonaFullførtIntegrasehemmere, HIV; HIV PROTEASE HEMMINGSpania
-
University of Maryland, BaltimoreTilbaketrukketHiv | Nyretransplantasjon | HIV-reservoar | CCR5Forente stater
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London og andre samarbeidspartnereRekrutteringHIV | HIV-testing | Kobling til omsorgSør-Afrika
-
National Taiwan UniversityRekruttering
-
Helios SaludViiV HealthcareUkjentHiv | HIV-1-infeksjonArgentina
Kliniske studier på Velferdstandard
-
M.D. Anderson Cancer CenterRekrutteringLungekreft | Mage-tarmkreftForente stater
-
University of Alabama at BirminghamTilbaketrukketFysisk aktivitetForente stater
-
University of FloridaPatient-Centered Outcomes Research InstituteAktiv, ikke rekrutterendeProstatakreftForente stater
-
University of Colorado, DenverRekruttering
-
Vanderbilt UniversityFullført
-
NRG OncologyNational Cancer Institute (NCI); Alliance for Clinical Trials in Oncology; Eastern Cooperative Oncology Group og andre samarbeidspartnereRekrutteringHER2-positiv brystkreftForente stater, Puerto Rico
-
The Cleveland ClinicSanten Inc.Aktiv, ikke rekrutterende
-
Henry M. Jackson Foundation for the Advancement...Boston University; Kenya Medical Research Institute; Kenya Ministry of Health og andre samarbeidspartnereFullført
-
Stanford UniversityFullførtNeonatal hypoglykemiForente stater