Evidence map›Paper›PMID 35255859›Full record

ArticleBMC public health2022

Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 × 2 factorial randomised controlled trial.

Glory Chidumwa, Natsayi Chimbindi, Carina Herbst, Nonhlanhla Okeselo, Jaco Dreyer, Thembelihle Zuma, Theresa Smith, Jean-Michel Molina, Thandeka Khoza, Nuala McGrath and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04532307 (Isisekelo Sempilo), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04532307 nacompletednot on this map

Isisekelo Sempilo: HIV Prevention Embedded in Sexual Health: A Pilot Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention and Care to Adolescents and Young Adults in Rural KwaZulu-Natal.

TypeinterventionalSponsorAfrica Health Research InstituteRan2020 to 2022Enrolled1,743ConditionsHIV PreventionArmsStandard of Care SOC, SRH enhanced Isisekelo Sempilo, Peer-support (Thetha-Nami), SOC + SRH + peer-support
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 24 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 5 institutions in 3 countries.

Glory ChidumwaAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Natsayi ChimbindiAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Carina HerbstAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Nonhlanhla OkeseloAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Jaco DreyerAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Thembelihle ZumaAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Theresa SmithAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Jean-Michel MolinaDepartment of Infectious Diseases, Hospitals Saint-Louis and Lariboisière, Paris, France.
Thandeka KhozaAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Nuala McGrathAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Janet SeeleyAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Deenan PillayUCL Institute for Global Health, 3rd Floor Mortimer Market Centre, Capper Street, London, WC1E 6JP, UK.
Frank TanserAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Guy HarlingAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Lorraine SherrUCL Institute for Global Health, 3rd Floor Mortimer Market Centre, Capper Street, London, WC1E 6JP, UK.
Andrew CopasUCL Institute for Global Health, 3rd Floor Mortimer Market Centre, Capper Street, London, WC1E 6JP, UK.
Kathy BaisleyAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa.
Maryam ShahmaneshAfrica Health Research Institute, Mtubatuba, KwaZulu-Natal, South Africa. m.shahmanesh@ucl.ac.uk.ORCID 0000-0001-7129-8535
Africa Health Research Institute · ZAMortimer Market Centre · GBLondon School of Hygiene & Tropical Medicine · GBDurban University of Technology · ZAHarvard University · US

Funding

Maximizing combination HIV prevention, uptake and retention by adolescent girls and young womenR01MH114560 · NIMH · KWAZULU-NATAL RESEARCH INSTITUTE TB-HIV · PI SHAHMANESH, MARYAM · 2017 to 2023
$2.0M
Department of HealthNIMH NIH HHS R01 MH114560Wellcome Trust 210479/Z/18/Z
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality, morbidity and incidence. Effective individual-level prevention modalities have not translated into population-level impact in southern Africa due to sub-optimal coverage among adolescents and youth who are hard to engage. We aim to investigate the feasibility, acceptability, and preliminary population level effectiveness of HIV prevention services with or without peer support to reduce prevalence of transmissible HIV amongst adolescents and young adults in KwaZulu-Natal.

methodsWe are conducting a 2 × 2 factorial trial among young men and women aged 16-29 years, randomly selected from the Africa Health Research Institute demographic surveillance area. Participants are randomly allocated to one of four intervention combinations: 1) Standard of Care (SOC): nurse-led services for HIV testing plus ART if positive or PrEP for those eligible and negative; 2) Sexual and Reproductive Health (SRH): Baseline self-collected vaginal and urine samples with study-organized clinic appointments for results, treatment and delivery of HIV testing, ART and PrEP integrated with SRH services; 3) Peer-support: Study referral of participants to a peer navigator to assess their health, social and educational needs and provide risk-informed HIV prevention, including facilitating clinic attendance; or 4) SRH + peer-support. The primary outcomes for effectiveness are: (1) the proportion of individuals with infectious HIV at 12 months and (2) uptake of risk-informed comprehensive HIV prevention services within 60 days of enrolment. At 12 months, all participants will be contacted at home and the study team will collect a dried blood spot for HIV ELISA and HIV viral load testing. DISCUSSION: This trial will enable us to understand the relative importance of SRH and peer support in creating demand for effective and risk informed biomedical HIV prevention and preliminary data on their effectiveness on reducing the prevalence of transmissible HIV amongst all adolescents and youth.

trial registrationTrial Registry: clincialtrials.gov. CLINICALTRIALS: gov Identifier NCT04532307 . Registered: March 2020.

Indexed as

Acquired Immunodeficiency SyndromeHIV InfectionsSexual HealthAdolescentAdultFemaleHumansMalePrevalenceRandomized Controlled Trials as TopicSouth AfricaYoung AdultCommunity-based careContraceptionHIV preventionPeer navigatorPre-Exposure prophylaxis

Identifiers

PMID35255859
PMCPMC8900304
OpenAlexW4220748839

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.