Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya

Abstract

We conducted an exploratory analysis of former HIV Prevention Trials Network 052 (HPTN 052) clinical trial participants in 2016 to assess their (1) satisfaction with the HPTN 052 clinical trial care and treatment, and reasons for joining the trial; and (2) perspectives about the post-trial transition to public HIV care centers. Quantitative data showed that, of the 70 survey participants, 94.3% (n = 66) reported being very satisfied with the care and treatment they received while participating in the clinical trial and 51.4% (n = 36) reported they joined the study because they would receive information to improve their own or their partner’s health. Qualitative data (five in-depth interviews and two focus group discussions) analysis revealed the following themes: transition experiences; perceived superior clinical trial care; study benefits not offered at public HIV care centers; and the public HIV care centers’ indifference to the uninfected partner. For some HPTN 052 participants, transition to HIV care clinics was disappointing. Clinical trial investigators and local Institutional Review Boards should consider the need for safeguards and oversight of post-trial health care for trial participants after the trial ends, especially in resource-constrained settings, to avoid negative health outcomes.

Keywords

Transition clinical trial HIV Prevention Trials Network 052 discordant couples Kenya NCT00074581 post-trial access ethics

Get full access to this article

View all access options for this article.

References

Pflugeisen

Rebar

Reedy

et al . Assessment of clinical trial participant patient satisfaction: A call to action. Trials 2016; 17: 483.

Verheggen

Nieman

Reerink

et al . Patient satisfaction with clinical trial participation. Int J Qual Health Care 1998; 10: 319–330.

Tangrea

Adrianza

Helsel

WE.

Patients' perceptions on participation in a cancer chemoprevention trial. Cancer Epidemiol Biomarkers Prev 1992; 1: 325–330.

Yehia

Long

Stearns

et al . Impact of transitioning from HIV clinical trials to routine medical care on clinical outcomes and patient perceptions. AIDS Care 2012; 24: 769–777.

Sofaer

Lewis

Davies

Forthcoming practical framework for ethics committees and researchers on post-trial access to the trial intervention and healthcare. J Med Ethics 2014; 40: 217–218.

Paul

Merritt

Sugarman

Implementing post-trial access plans for HIV prevention research. J Med Ethics 2018; 44: 354–358.

Dal-Re

Rid

Emanuel

et al . The potential exploitation of research participants in high income countries who lack access to health care. Br J Clin Pharmacol 2016; 81: 857–864.

Ondenge

Renju

Bonnington

et al . 'I am treated well if I adhere to my HIV medication': Putting patient–provider interactions in context through insights from qualitative research in five sub-Saharan African countries. Sex Transm Infect 2017; 93(3): e052973.

Ware

Wyatt

Geng

et al . Toward an understanding of disengagement from HIV treatment and care in sub-Saharan Africa: A qualitative study. PLoS Med 2013; 10: e1001369.

10.

Cohen

Chen

McCauley

et al . Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365: 493–505.

11.

Ahmad

Howard

Brooks

et al . The role of platelet rich plasma in musculoskeletal science. J R Soc Med Short Rep 2012; 3: 40.

12.

MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. Guidance Document [Version 1.2, November 2017], http://mrctcenter.org/wp-content/uploads/2017/06/2017-06-28-Post-Trial-Responsibilities-Guidance-Document-Version-1.1.pdf (accessed 20 June 2018).

13.

MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. MRCT Center Post-Trial Responsibilities Toolkit [Version 1.1, November 2017]. MRCT Center, http://mrctcenter.org/wp-content/uploads/2017/06/2017-06-26-Post-Trial-Responsibilities-Toolkit-Version-1.0-1.pdf (accessed 20 June 2018).

14.

Kenya National AIDS and STIs Control Programme. Kenya AIDS Indicator Survey 2012: Final Report. Nairobi, NASCOP, www.naccorke/images/documents/KAIS-2012pdf (2014) (accessed 17 November 2017).

15.

Wamoyi

Renju

Moshabela

et al . Understanding the relationship between couple dynamics and engagement with HIV care services: Insights from a qualitative study in Eastern and Southern Africa. Sex Transm Infect 2017; 93(3): e052975.

16.

Kenya Institute for Public Policy Research and Analysis (KIPPRA). Kenya Economic Report 2012, http://kippraorke/indexphp?option=com_docman&task=doc_view&gid=274&Itemid= (2012) (accessed 1 November 2017).

17.

Bogart

Chetty

Giddy

et al . Barriers to care among people living with HIV in South Africa: Contrasts between patient and healthcare provider perspectives. AIDS Care 2013; 25: 843–853.

18.

Rankin

When docs get annoyed at empowered patients, www.psychologytodaycom/blog/owning-pink/201107/when-docs-get-annoyed-empowered-patients (2011) (accessed 15 October 2017).

19.

Higgins

Mathur

Eckel

et al . Importance of relationship context in HIV transmission: Results from a qualitative case-control study in Rakai, Uganda. Am J Public Health 2014; 104: 612–620.

20.

Jiwatram-Negron

El-Bassel

Systematic review of couple-based HIV intervention and prevention studies: Advantages, gaps, and future directions. AIDS Behav 2014; 18: 1864–1887.

21.

El-Bassel

Wechsberg

WM.

Couple-based behavioral HIV interventions: Placing HIV risk-reduction responsibility and agency on the female and male dyad. Couple Fam Psychol: Res Pract 2012; 1: 94–105.

22.

Burton

Darbes

Operario

Couples-focused behavioral interventions for prevention of HIV: Systematic review of the state of evidence. AIDS Behav 2010; 14: 1–10.

23.

Henderson

Churchill

Davis

et al . Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 2007; 4: e324.

24.

Aellah

Chantler

Geissler

Global health research in an unequal world: Ethics case studies from Africa. LCCN 2016019492, www.ncbinlmnihgov/books/NBK458764/ (2016) ISBN 9781786390042 (accessed 30 September 2017).

25.

Emanuel

Wendler

Killen

et al . What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 2004; 189: 930–937.

26.

The Medicines for Human Use (Clinical Trials) Regulations 2004, www.legislation.gov.uk/uksi/2004/1031 (2004) (accessed 22 October 2017).

27.

Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) (CIOMS-WHO). International Ethical Guidelines for Health-related Research Involving Humans, https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf (2016) (accessed 3 November 2017).

28.

Cho

Danis

Grady

Post-trial responsibilities beyond post-trial access. Lancet 2018; 391: 1478–1479.