Evidence map›Paper›PMID 30370830›Full record

Trial reportHIV clinical trials2018

Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study.

Joshua Wynne, Rosemary Muwawu, Michael C Mubiru, Betty Kamira, Doreen Kemigisha, Teopista Nakyanzi, Samuel Kabwigu, Clemensia Nakabiito, Flavia Kiweewa Matovu

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in HIV clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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

9 authors.

Joshua Wynnea Sidney Kimmel Medical College at Thomas Jefferson University , Philadelphia , Pennsylvania , USA.
Rosemary Muwawub Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Michael C Mubirub Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Betty Kamirab Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Doreen Kemigishab Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Teopista Nakyanzib Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Samuel Kabwigub Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Clemensia Nakabiitob Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.
Flavia Kiweewa Matovub Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration , Kampala , Uganda.ORCID 0000-0002-0046-4353

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

backgroundThe success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results.

objectiveThis paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda.

methodsOnce enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Challenges to retention included a mobile population, non-disclosure of study participation to spouse/family, and economic constraints. Strategies used to maintain high participation rates included the use of detailed locator information, a participant tracking database, regular HIV/STI testing, and the formation of close bonds between staff and subjects.

resultsWe enrolled 322 women out of the 637 screened. The overall retention rate was 95% over a 3 year follow up period. Only 179 (3%) out of the 6124 expected visits were missed throughout study implementation. Reasons for missed visits included: participants thinking that they did not need frequent visits due to their HIV negative status, time constraints due to commercial sex work, and migration for better employment.

conclusionsWith the implementation of multi-faceted comprehensive follow-up and retention strategies, we achieved very high retention rates in the MTN-003 study. This paper provides a blueprint for effective participant retention strategies for other longitudinal HIV prevention studies in resource-limited settings in Sub-Saharan Africa.

Indexed as

Patient ParticipationAdministration, IntravaginalAdministration, OralAdultAlbuterol, Ipratropium Drug CombinationAnti-HIV AgentsClinical Trials as TopicEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleGelsHIV InfectionsHumansLongitudinal StudiesTenofovirUgandaAlbuterol, Ipratropium Drug CombinationAnti-HIV AgentsEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationGelsTenofovirclinical trialsHIVPrEPpreventionretentionSub-Saharan AfricaUganda

Identifiers

PMID30370830
PMCPMC6614555

What OpenQuestion holds

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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.