Evidence map›Paper›PMID 22023776›Full record

Trial reportBMC infectious diseases2011

A qualitative evaluation of volunteers' experiences in a phase I/II HIV vaccine trial in Tanzania.

Edith A M Tarimo, Anna Thorson, Thecla W Kohi, Muhammad Bakari, Eric Sandstrom, Fred Mhalu, Asli Kulane

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in BMC infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 22% 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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 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

7 authors at 3 institutions in 2 countries.

Edith A M TarimoDivision of Global Health (IHCAR), Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. etarimo54@yahoo.co.uk
Anna Thorson
Thecla W Kohi
Muhammad Bakari
Eric Sandstrom
Fred Mhalu
Asli Kulane
Karolinska Institutet · SEMuhimbili University of Health and Allied Sciences · TZStockholm South General Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvaluating experiences of volunteers in an HIV vaccine trial will be useful for the conduct of future trials. The purpose of this study among volunteers who participated in a phase I/II HIV vaccine trial in Dar es Salaam, Tanzania was to assess what characterized their experiences during the trial.

methodsWe conducted four focus group discussions with 35 out of the 60 individuals (women and men) after the five scheduled vaccinations. An interpretive description approach was applied to data analysis.

resultsAs a result of the trial interventions, both men and women gained confidence in their own abilities to have safer, less risky sexual behaviour. The participants experienced the trial as a way of accessing free [insured] medical services. Most of the men said they had gone from self-medication to professional medical consultation. Despite these benefits, the participants faced various challenges during the trial. Such challenges included mistrust of the trial shown by health care providers who were not connected to the trial and discouragement from friends, colleagues and family members who questioned the safety of the trial. However, they managed to cope with these doubts by using both personal and trial related interventions.

conclusionWe found that during the phase I/II HIV vaccine trial, participants had both the opportunities and the ability to cope with the doubts from the surrounding community. Follow up visits enhanced the opportunities and individuals' abilities to cope with the doubts during the trial. Understanding this discourse may be useful for the trial implementers when designing future trials. TRIALS REGISTRATION: ISRCTN: ISRCTN90053831 Pan African Clinical Trials Registry (PACTR): ATMR2009040001075080.

Indexed as

Human ExperimentationAdultAIDS VaccinesBehaviorEvaluation Studies as TopicFemaleFocus GroupsFollow-Up StudiesHIV InfectionsHumansMaleTanzaniaAIDS Vaccines

Identifiers

PMID22023776
PMCPMC3215708
OpenAlexW2127697117

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.