Evidence map›Paper›PMID 37147725›Full record

ArticleTrials2023

Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa-a multiphase optimization strategy (MOST) approach using a fractional factorial design.

Lauren Jennings, Rebecca L West, Nafisa Halim, Jeanette L Kaiser, Marya Gwadz, William B MacLeod, Allen L Gifford, Jessica E Haberer, Catherine Orrell, Lora L Sabin

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

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05040841 (Supporting Sustained HIV Treatment Adherence After Initiation), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 27% 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.

NCT05040841 nacompletednot on this map

Supporting Sustained HIV Treatment Adherence After Initiation

TypeinterventionalSponsorBoston UniversityRan2022 to 2026Enrolled534ConditionsHIV Infections, Adherence, MedicationArmsM1/OTR: Immediate outreach to subject due to unsuppressed viral load test result, M2/PRM: Immediate outreach to subject after a missed pharmacy refill, M3/EAM: Immediate outreach to subject after EAM-identified missed doses, S1/Text: Weekly check-in texts, S2/Peer: Enhanced peer group support
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. A Study on AIDS Self-Management Status and Its Influencing Factors.Journal of multidisciplinary healthcare · 2024
    Article
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

10 authors at 4 institutions in 2 countries.

Lauren JenningsDesmond Tutu Health Foundation, Institute of Infectious Diseases and Molecular Medicine and the Department of Medicine, University of Cape Town, Cape Town, South Africa. lauren.jennings@hiv-research.org.za.ORCID http://orcid.org/0000-0003-4749-2404
Rebecca L WestDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Nafisa HalimDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Jeanette L KaiserDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Marya GwadzSilver School of Social Work, New York University, New York, NY, USA.
William B MacLeodDepartment of Global Health, Boston University School of Public Health, Boston, MA, USA.
Allen L GiffordSection of General Internal Medicine, Department of Medicine, Boston University School of Medicine, 72 E Concord Street, Boston, MA, 02118, USA.
Jessica E HabererCenter for Global Health, Massachusetts General Hospital, Boston, MA, USA.
Catherine Orrell *Desmond Tutu Health Foundation, Institute of Infectious Diseases and Molecular Medicine and the Department of Medicine, University of Cape Town, Cape Town, South Africa.
Lora L Sabin *Department of Global Health, Boston University School of Public Health, Boston, MA, USA.
Boston University · USDesmond Tutu HIV Foundation · ZAHarvard University · USNew York University · US

Funding

Supporting Sustained HIVTreatment Adherence after Initiation (SUSTAIN)R01MH125703 · NIMH · BOSTON UNIVERSITY MEDICAL CAMPUS · PI ORRELL, CATHERINE, SABIN, LORA L · 2021 to 2025
$2.9M
NIMH NIH HHS 1R01MH125703-O1A1NIMH NIH HHS R01 MH125703
6 · The paper itself

Abstract

backgroundSouth Africa bears a large HIV burden with 7.8 million people with HIV (PWH). However, due to suboptimal antiretroviral therapy (ART) adherence and retention in care, only 66% of PWH in South Africa are virally suppressed. Standard care only allows for suboptimal adherence detection when routine testing indicates unsuppressed virus. Several adherence interventions are known to improve HIV outcomes, yet few are implemented in routinely due to the resources required. Therefore, determining scalable evidence-based adherence support interventions for resource-limited settings (RLS) is a priority. The multiphase optimization strategy (MOST) framework allows for simultaneous evaluation of multiple intervention components and their interactions. We propose to use MOST to identify the intervention combination with the highest levels of efficacy and cost-effectiveness that is feasible and acceptable in primary care clinics in Cape Town.

methodsWe will employ a fractional factorial design to identify the most promising intervention components for inclusion in a multi-component intervention package to be tested in a future randomized controlled trial. We will recruit 512 participants initiating ART between March 2022 and February 2024 in three Cape Town clinics and evaluate acceptability, feasibility, and cost-effectiveness of intervention combinations. Participants will be randomized to one of 16 conditions with different combinations of three adherence monitoring components: rapid outreach following (1) unsuppressed virus, (2) missed pharmacy refill collection, and/or (3) missed doses as detected by an electronic adherence monitoring device; and two adherence support components: (1) weekly check-in texts and (2) enhanced peer support. We will assess viral suppression (<50 copies/mL) at 24 months as the primary outcome; acceptability, feasibility, fidelity, and other implementation outcomes; and cost-effectiveness. We will use logistic regression models to estimate intervention effects with an intention-to-treat approach, employ descriptive statistics to assess implementation outcomes, and determine an optimal intervention package. DISCUSSION: To our knowledge, ours will be the first study to use the MOST framework to determine the most effective combination of HIV adherence monitoring and support intervention components for implementation in clinics in a RLS. Our findings will provide direction for pragmatic, ongoing adherence support that will be key to ending the HIV epidemic.

trial registrationClinicalTrials.gov NCT05040841. Registered on 10 September 2021.

Indexed as

Anti-HIV AgentsHIV InfectionsAnti-Retroviral AgentsHumansMedication AdherencePragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSouth AfricaAnti-HIV AgentsAnti-Retroviral AgentsAntiretroviralsBehavior changeElectronic adherence monitoringHIVMedication adherenceMOST framework

Identifiers

PMID37147725
PMCPMC10163747
OpenAlexW4372218513

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.