Evidence map›Paper›PMID 40611238›Full record

SynthesisBMC medical ethics2025

Descriptions of risks and benefits of HIV vaccine trials in low-and middle-income countries (LMICs): an integrative review.

Judith Shayo, Deodatus Sabas, Adamu Addissie, Eligius Lyamuya, Connie Ulrich

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

5 authors.

Judith ShayoMuhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es salaam, Tanzania. judiedward@yahoo.com.
Deodatus SabasMuhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es salaam, Tanzania.
Adamu AddissieAddis Ababa University, School of Public Health, Addis Ababa, P.O. Box 366, Code, 1029, Ethiopia.
Eligius LyamuyaMuhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es salaam, Tanzania.
Connie UlrichNewCourtland Center for Transitions and Health, University of Pennsylvania School of Nursing and Perelman School of Medicine, Leonard Davis Institute of Health Economics, Philadelphia, USA.

Funding

This review is part of a PhD study funded by Fogarty International Center, NIH International Research Training Grant. [D43TW011809]
6 · The paper itself

Abstract

Human immunodeficiency virus (HIV) vaccine trials are needed in efforts to prevent infection and acquired immunodeficiency syndrome (AIDS). Like other types of research, HIV vaccine trials present benefits and risks that may or may not be anticipated by participants. Perceptions of risks and benefits often vary with contextual factors, such as sociocultural and economic variables, which are important in low- and middle-income countries (LMICs).

aimsThis integrative review aimed to determine the risks and benefits of HIV vaccine trial participation reported in the LMICs from 1995 to 2024. The risks and benefits were reported by participants and potential participants during trial preparations, recruitment, actual trial participation or after trial participation. In this review we assessed on how the risks and benefits were described by the authors of the reviewed studies. We also sought to categorize these risks and benefits, consider ethical implications, identify gaps for further research, and recommend actions for policy improvement.

methodsThe integrative review screened studies from four databases (CINAHL, Embase, MEDLINE and Web of Science). Studies were eligible if they involved interactions with human subjects and were written in English. Covidence software was used to organize the search outcomes. RESULTS AND DISCUSSION: Twenty-five studies met inclusion criteria. Identified benefits included a sense of altruism, free healthcare, financial incentives and HIV education. Risks included stigma and discrimination associated with vaccine-induced seropositivity, perceived racism and fear of delayed harms. Important descriptions of risks and benefits (e.g., magnitude and likelihood) were missing. Free healthcare and financial incentives may render participants too influenced to enter consent, which is an important ethical concern in LMICs.

conclusionThe literature was scant, highlighting a need for research on how participants in LMICs are informed about weighing risks and benefits of HIV vaccine trial participation. More in-depth description of risks and benefits is warranted. Standardized risk/benefit assessment frameworks tailored to the context of these trials in LMICs are needed.

Indexed as

AIDS VaccinesClinical Trials as TopicDeveloping CountriesHIV InfectionsHumansRisk AssessmentAIDS VaccinesBenefitDescription“HIV vaccine trials”Integrative review“Low-and-Middle income countries”Risk

Identifiers

PMID40611238
PMCPMC12224502

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.