Article Text
Abstract
Introduction Reaching men aged 20–35 years, the group at greatest risk of HIV, with voluntary medical male circumcision (VMMC) remains a challenge. We assessed the impact of two VMMC demand creation approaches targeting this age group in a randomised controlled trial (RCT).
Methods We conducted a 2×2 factorial RCT comparing arms with and without two interventions: (1) standard demand creation augmented by human-centred design (HCD)-informed approach; (2) standard demand creation plus offer of HIV self-testing (HIVST). Interpersonal communication (IPC) agents were the unit of randomisation. We observed implementation of demand creation over 6 months (1 May to 31 October 2018), with number of men circumcised assessed over 7 months. The primary outcome was the number of men circumcised per IPC agent using the as-treated population of actual number of months each IPC agent worked. We conducted a mixed-methods process evaluation within the RCT.
Results We randomised 140 IPC agents, 35 in each arm. 132/140 (94.3%) attended study training and 105/132 (79.5%) reached at least one client during the trial period and were included in final analysis. There was no evidence that the HCD-informed intervention increased VMMC uptake versus no HCD-informed intervention (incident rate ratio (IRR) 0.87, 95% CI 0.38 to 2.02; p=0.75). Nor did offering men a HIVST kit at time of VMMC mobilisation (IRR 0.65, 95% CI 0.28 to 1.50; p=0.31). Among IPC agents that reported reaching at least one man with demand creation, both the HCD-informed intervention and HIVST were deemed useful. There were some challenges with trial implementation; <50% of IPC agents converted any men to VMMC, which undermined our ability to show an effect of demand creation and may reflect acceptability and feasibility of the interventions.
Conclusion This RCT did not show evidence of an effect of HCD-informed demand intervention or HIVST on VMMC uptake. Findings will inform future design and implementation of demand creation evaluations.
Trial registration number PACTR201804003064160.
- HIV
- health services research
- public health
- randomised control trial
Data availability statement
Data are available upon request. Data from our trial will be made available upon request to the London School of Hygiene & Tropical Medicine data repository. https://datacompass.lshtm.ac.uk/.
This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (CC BY NC 3.0 IGO), which permits use, distribution,and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL.Disclaimer: The author is a staff member of the World Health Organization. The author alone is responsible for the views expressed in this publication and they do not necessarily represent the views, decisions or policies of the World Health Organization.
Statistics from Altmetric.com
Data availability statement
Data are available upon request. Data from our trial will be made available upon request to the London School of Hygiene & Tropical Medicine data repository. https://datacompass.lshtm.ac.uk/.
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Handling editor Seye Abimbola
Twitter @webstermavhu, @melneuman, @SungaiChabata, @cmangenah01, @ccasejohn
Contributors WM, FMC and KH led the trial design, with involvement from HAW, MN and KLF. WM, FMC and MN conceived and designed the study protocol. KH, NT, NM and MM developed the intervention, with support from GN, SX and OM. WM, FMC, SB and CM led the trial implementation, data collection and process evaluation. MN, GM and STC carried out the statistical analysis, with support from HAW and KLF. WM, FMC, MN, KLF, SB and CM led data interpretation with involvement from KH, GM, STC, CM, NT, NM, MM, GN, SX, OM, CJ, ELC and HAW. WM, FMC, MN and KLF wrote the paper and all authors were involved in the review of drafts. All authors have approved the final manuscript.
Funding Bill & Melinda Gates Foundation; Unitaid as part of the STAR Initiative. Unitaid is a hosted partnership of the World Health Organisation. The funders had no role in study design, data collection, data analysis, data interpretation or writing of the report.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.