Considerations for Informed Consent Process for a Rehabilitation Program for People Living with HIV/AIDS in a Lower Middle Income Country


The numerous benefits of exercise programs for rehabilitation in HIV/AIDS have been documented, yet participation in exercise and its research is low within this group. The reasons for consenting or not consenting to research in this area are still unclear. Empirical research can reveal and proffer solution to challenges surrounding consenting and participating in a rehabilitation program. The objective of this study was to describe possible reasons for not consenting to a 12-week exercise class for people living with HIV/AIDS.

In the course of recruiting participants for a 12-week exercise program for rehabilitation in HIV/AIDS, observations and qualitative interviews were conducted with a focus on the consenting process. Participants were recruited using convenience sampling and a semi-structured qualitative interview guide was used. Qualitative analysis revealed several themes related to the informed consent process. The sample size for the study was calculated using the Fisher’s equation based on a national HIV prevalence of 3.6% giving a sample size of 58 participants.

A total of 103 adults living with HIV who participated in a health talk were invited to the rehabilitation program. Eighty-five individuals indicated an interest to participate in the program. Fifty-two persons consented to the exercise program while 33 persons declined after hesitation to participate and were the focus of this study. Their age range was between 18-64 years with an uneven gender distribution: men (n=12) 33.3%; women (n = 21) 63.6%. Emerging themes from qualitative analysis revealed concerns about having to obtain frequent permission from work, business, or home to attend the program for 12 weeks, a need to obtain permission from husband and/or family members before consenting, non-disclosure of status to spouse, friends, colleagues and family, fear of worsened health conditions if exercise program is terminated, busy life schedules, and gender role expectations.

This study showed how potential research participants perceived enrollment in a physical exercise program for 12 weeks. It demonstrated the varying reasons for non-participation in this type of study even though they were aware of the benefits. 

Limitations and Recommendations
This study focused on those that did not give consent. A more robust study delineating reasons for consenting is recommended. The orthodox ethical principles of human subject research were in place here, but there is a need to further understand the influence of factors like culture and gender role perceptions on these principles.