Restricted accessResearch articleFirst published online 2025-1
Intervention Fidelity to VITAL Start (Video Intervention to Inspire Treatment Adherence for Life) in a Randomized Controlled Trial Among Women Living With HIV in Malawi
Intervention effectiveness in a randomized controlled trial is attributed to intervention fidelity. Measuring fidelity has increasing significance to intervention research and validity. The purpose of this article is to describe a systematic assessment of intervention fidelity for VITAL Start (Video intervention to Inspire Treatment Adherence for Life)—a 27-minute video-based intervention designed to improve antiretroviral therapy adherence among pregnant and breastfeeding women.
Method.
Research Assistants (RAs) delivered VITAL Start to participants after enrolment. The VITAL Start intervention had three components: a pre-video orientation, video viewing, and post-video counseling. Fidelity assessments using checklists comprised self (RA assessment) and observer (Research Officers, also known as ROs) assessment. Four fidelity domains (adherence, dose, quality of delivery, and participant responsiveness) were evaluated. Score scale ranges were 0 to 29 adherence, 0 to 3 dose, 0 to 48 quality of delivery and 0 to 8 participant responsiveness. Fidelity scores were calculated. Descriptive statistics summarizing the scores were performed.
Results.
In total, eight RAs delivered 379 VITAL Start sessions to 379 participants. Four ROs observed and assessed 43 (11%) intervention sessions. The mean scores were 28 (SD = 1.3) for adherence, 3 (SD = 0) for dose, 40 (SD = 8.6) for quality of delivery, and 10.4 (SD = 1.3) for participant responsiveness.
Conclusion.
Overall, the RAs successfully delivered the VITAL Start intervention with high fidelity. Intervention fidelity monitoring should be an important element of randomized control trial design of specific interventions to ensure having reliable study results.
AltmanD. G.SchulzK. F.MoherD.EggerM.DavidoffF.ElbourneD.LangT., & CONSORT GROUP (Consolidated Standards of Reporting Trials). (2001). The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Annals of Internal Medicine, 134(8), 663–694. https://doi.org/10.7326/0003-4819-134-8-200104170-00012
2.
AnM.DusingS. C.HarbourneR. T.SheridanS. M. (2020). What really works in intervention? Using fidelity measures to support optimal outcomes. Physical Therapy, 100(5), 757–765. https://doi.org/10.1093/ptj/pzaa006
3.
BellgA. J.BorrelliB.ResnickB.HechtJ.MinicucciD. S.OryM.OgedegbeG.Denise, OrwigG.ErnstD.CzajkowskiS., & Treatment Fidelity Workgroup of the NIH Behavior Change Consortium (2004). Enhancing treatment fidelity in health behavior change studies: Best practices and recommendations from the NIH behavior change consortium. Health Psychology, 23(5), 443–451. https://doi.org/10.1037/0278-6133.23.5.443
4.
BonellC.FletcherA.MortonM.LorencT.MooreL. (2012). Realist randomised controlled trials: A new approach to evaluating complex public health interventions. Social Science & Medicine, 75(12), 2299–2306. https://doi.org/10.1016/j.socscimed.2012.08.032
5.
BroekhuizenK.AlthuizenE.van PoppelM. N.DonkerM.van MechelenW. (2012). From theory to practice: Intervention fidelity in a randomized controlled trial aiming to optimize weight development during pregnancy. Health Promotion Practice, 13(6), 816–825. https://doi.org/10.1177/1524839912447190
6.
CarrollC.PattersonM.WoodS.BoothA.RickJ.BalainS. (2007). A conceptual framework for implementation fidelity. Implementation Science, 2, Article 40. https://doi.org/10.1186/1748-5908-2-40
7.
ChagomeranaM. B.MillerW. C.TangJ. H.HoffmanI. F.MthikoB. C.PhulusaJ.JohnM.JumbeA.HosseinipourM. C. (2018). Optimizing prevention of HIV mother to child transmission: Duration of antiretroviral therapy and viral suppression at delivery among pregnant Malawian women. PLOS ONE, 13(4), Article e0195033. https://doi.org/10.1371/journal.pone.0195033
8.
ChangP. S.ChaoA. M.JangM.LuY. Y. F. (2019). Intervention fidelity in Qigong randomized controlled trials: A method review. Geriatric Nursing, 40(1), 84–90. https://doi.org/10.1016/j.gerinurse.2018.07.001
9.
DaviesD. R.ShackletonV. J. (1975). Psychology and work. London: Methuen.
10.
DumasJ. E.LynchA. M.LaughlinJ. E.Phillips SmithE.PrinzR. J. (2001). Promoting intervention fidelity: Conceptual issues, methods, and preliminary results from the EARLY ALLIANCE prevention trial. American Journal of Preventive Medicine, 20(1 Suppl.), 38–47. https://doi.org/10.1016/s0749-3797(00)00272-5
11.
DusenburyL. B. R.FalcoM.HansenW. B. (2003). A review of research on fidelity of implementation: Implications for drug abuse prevention in school settings. Health Education Research, 18(2), 237–256. https://academic.oup.com/her/article/18/2/237/820533
12.
DyasJ. V.TogherF.SiriwardenaA. N. (2014). Intervention fidelity in primary care complex intervention trials: Qualitative study using telephone interviews of patients and practitioners. Quality in Primary Care, 22(1), 25–34.
13.
FeelyM.SeayK. D.LanierP.AuslanderW.KohlP. L. (2018). Measuring fidelity in research studies: A field guide to developing a comprehensive fidelity measurement system. Child and Adolescent Social Work Journal, 35(2), 139–152. https://doi.org/10.1007/s10560-017-0512-6
14.
FrenchC. T.DiekemperR. L.IrwinR. S., & CHEST Expert Cough Panel. (2015). Assessment of intervention fidelity and recommendations for researchers conducting studies on the diagnosis and treatment of chronic cough in the adult: CHEST guideline and expert panel report. Chest, 148(1), 32–54. https://doi.org/10.1378/chest.15-0164
15.
Gaitán-RossiP.De la Cerda LobatoS.Pérez NavarroA. C.Aguilar EstevaA.Vargas GarcíaM. R.Vilar-CompteM. (2019). Fidelity of implementation of Prospera digital: Evaluation of a multi-site mHealth intervention aimed at improving maternal health outcomes in Mexico. Current Developments in Nutrition, 3(10), Article nzz107. https://doi.org/10.1093/cdn/nzz107
16.
HaasA. D.TenthaniL.MsukwaM. T.TalK.JahnA.GadabuO. J.SpoerriA.ChimbwandiraF.van OosterhoutJ. J.KeiserO. (2016). Retention in care during the first 3 years of antiretroviral therapy for women in Malawi’s option B+ programme: An observational cohort study. The Lancet HIV, 3(4), e175–e182. https://doi.org/10.1016/S2352-3018(16)00008-4
17.
HaritonE.LocascioJ. J. (2018). Randomised controlled trials—The gold standard for effectiveness research: Study design: Randomised controlled trials. BJOG: An International Journal of Obstetrics & Gynaecology, 125(13), Article 1716. https://doi.org/10.1111/1471-0528.15199
18.
KimM. H.AhmedS.TemboT.SabelliR.FlickR.YuX.MazengaA.Le BlondH.SimonK.HartigM.WetzelENyirendaR.KazembeP. N.MphandeM.MkandawireA.ChitaniM. J.AbramsE. J. (2019). VITAL start: Video-based intervention to inspire treatment adherence for life-pilot of a novel video-based approach to HIV counseling for pregnant women living with HIV. AIDS and Behavior, 23(11), 3140–3151. https://doi.org/10.1007/s10461-019-02634-1
19.
KimM. H.TemboT. A.MazengaA.YuX.MyerL.SabelliR.FlickR.HartigM.WetzelE.SimonK.AhmedS.NyirendaR.KazembeP. N.MphandeM.MkandawireA.ChitaniM. J.MarkhamC.CiaranelloA.AbramsE. J. (2020). The video intervention to inspire treatment adherence for life (VITAL Start): Protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi. Trials, 21(1), Article 207. https://doi.org/10.1186/s13063-020-4131-8
20.
LandesM.van LettowM.NkhomaE.Tippett BarrB.TruwahZ.ShoutenE.JahnA.AuldA.KaluaT.van OosterhoutJ. J. (2019). Low detectable postpartum viral load is associated with HIV transmission in Malawi’s prevention of mother-to-child transmission programme. Journal of the International AIDS Society, 22(6), Article e25290.
MarsT.EllardD.CarnesD.HomerK.UnderwoodM.TaylorS. J. C. (2013). Fidelity in complex behaviour change interventions: A standardised approach to evaluate intervention integrity. British Medical Journal Open, 3(11), Article e003555. https://doi.org/10.1136/bmjopen-2013-003555
23.
McGuireR.DuncanK.PozehlB. (2019). Incorporating intervention fidelity components into randomized controlled trials promoting exercise adherence in heart failure patients. Research in Nursing & Health, 42(4), 306–316. https://doi.org/10.1002/nur.21949
24.
MihalicS. (2004). The importance of implementation fidelity. Emotional and Behavioral Disorders in Youth, 4(4), 83–105.
25.
MishimaN.KubotaS.NagataS. (2000). The development of a questionnaire to assess the attitude of active listening. Journal of Occupational Health, 42(3), 111–118. https://doi.org/10.1539/joh.42.111
26.
NobleA. J.SnapeD.RidsdaleL.MorganM.NevittS. J.GoodacreS.MarsonA. (2019). Assessing treatment fidelity within an epilepsy randomized controlled trial: Seizure first aid training for people with epilepsy who visit emergency departments. Behavioural Neurology, 2019, Article 5048794. https://doi.org/10.1155/2019/5048794
27.
ProctorE.SilmereH.RaghavanR.HovmandP.AaronsG.BungerA.GriffeyR.HensleyM. (2011). Outcomes for implementation research: Conceptual distinctions, measurement challenges, and research agenda. Administration and Policy in Mental Health, 38(2), 65–76. https://doi.org/10.1007/s10488-010-0319-7
28.
SongM. K.HappM. B.SandelowskiM. (2010). Development of a tool to assess fidelity to a psycho-educational intervention. Journal of Advanced Nursing, 66(3), 673–682.
29.
SprangeK.MountainG.CraigC. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention lifestyle matters: A randomised controlled trial. British Medical Journal Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478
30.
StainsM.VickreyT. (2017). Fidelity of implementation: An overlooked yet critical construct to establish effectiveness of evidence-based instructional practices. CBE: Life Sciences Education, 16(1), Article 0113. https://doi.org/10.1187/cbe.16-03-0113
31.
StockdaleS. E.HamiltonA. B.BergmanA. A.RoseD. E.GiannitrapaniK. F.DresselhausT. R.YanoE. M.RubensteinL. V. (2020). Assessing fidelity to evidence-based quality improvement as an implementation strategy for patient-centered medical home transformation in the veterans health administration. Implementation Science, 15(1), Article 18. https://doi.org/10.1186/s13012-020-0979-y
32.
Sweeney-MageeM.KaleD.GaltonS.HamillA.GilbertH. (2016). Assessing the fidelity of delivery of an intervention to increase attendance at the English stop smoking services. Implementation Science, 11(1), Article 166. https://doi.org/10.1186/s13012-016-0498-z
33.
TangS.TongF.IrbyB. J.Lara-AlecioR.GuerreroC. (2020). Fidelity of implementation in a randomized controlled trial study: The effect of virtual professional development on bilingual teachers. Bilingual Research Journal, 43(1), 111–124. https://doi.org/10.1080/15235882.2019.1711268
34.
TenthaniL.HaasA. D.TweyaH.JahnA.van OosterhoutJ. J.ChimbwandiraF.ChirwaZ.Ng’ambiW.BakaliA.PhiriS.MyerL.ValeriF.ZwahlenM.WandelerG.KeiserO. (2014). Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women (“Option B+”) in Malawi. AIDS, 28(4), 589–598. https://doi.org/10.1097/qad.0000000000000143
35.
Tippett BarrB.SchoutenE.OosterhoutJ.GuptaS.PhiriH.ChimbwandiraF.ThindwaD.BlairC.JahnA.LettowM. (2016). National HIV transmission in 4–12 week olds in Malawi’s PMTCT option B+ program. In Proceedings of the Conference of Retroviruses and Opportunistic Infections.
36.
ToomeyE.HardemanW.HankonenN.ByrneM.McSharryJ.Matvienko-SikarK.LorencattoF. (2020). Focusing on fidelity: Narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions. Health Psychology and Behavioral Medicine, 8(1), 132–151. https://doi.org/10.1080/21642850.2020.1738935
37.
University of Wales College of Medicine. (2002). The Behaviour Change Counselling Index (BECCI): Manual for coding behaviour change counselling.
38.
WebsterT. R.MantopoulosJ.JacksonE.Cole-LewisH.KidaneL.KebedeS.AbebeY.LawsonR.BradleyE. H. (2011). A brief questionnaire for assessing patient healthcare experiences in low-income settings. International Journal for Quality in Health Care, 23(3), 258–268. https://doi.org/10.1093/intqhc/mzr019
39.
WickershamK.ColbertA.CaruthersD.TamresL.MartinoA.ErlenJ. (2011). Assessing fidelity to an intervention in a randomized controlled trial to improve medication adherence. Nursing Research, 60, 264–269. https://doi.org/10.1097/NNR.0b013e318221b6e6
40.
WolgemuthJ. R.AbramiP. C.HelmerJ.SavageR.HarperH.LeaT. (2014). Examining the impact of ABRACADABRA on early literacy in Northern Australia: An implementation fidelity analysis. The Journal of Educational Research, 107(4), 299–311.
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