Study design
Between December 2014 and November 2015, a 12-month longitudinal survey was conducted in Gokwe South, a rural district in Midlands province, Zimbabwe. Gokwe South District is a communal farming, informal mining community. The study used a randomised trial research design (Fig. 1). Three study sites were randomly selected in consultation with the MoHCC, including two clinics in the intervention arm and one larger clinic in the control arm.
Study participants
Ninety-four ALHIV, 10–15 years old, on ART, were recruited to the study from the three study sites (2 intervention and one control). Random number generation in Microsoft Excel was used to generate the random allocation sequence, with 47 participants allocated in each arm. The study used blocked randomisation with a block size of 10 which is ideal given the small sample size. The Ministry of Health and Child Care with technical assistance from Bristol Myers-Squibb generated the random allocation sequence used to assign participants to the control and intervention arm and enrolled the participants to the study. All participants were on ART, aware of their HIV status and not involved with other support services. Participants were all receiving their HIV treatment and care at the study sites prior to the start of the study. At each study site, eligible participants were informed of the study during their routine clinic visit and invited to participate in the study.
Standard of care
Participants in the control arm received the standard of care provided by the MoHCC, including monthly clinic reviews, ART, adherence counselling, CD4 monitoring and management of opportunistic infections. Treatment and care was led by a nurse and/or a primary counsellor.
Intervention
Participants in the intervention arm received the same standard of care, but were also allocated to one of nine trained and mentored CATS for additional support. This included a weekly home visit during which the allocated CATS provided HIV and ART information and counselling as well as monitored the participants’ adherence and general well-being. In the event that the participant was unwell or faced difficulties with adherence, the CATS would refer the participant to the CATS mentor in their district. The mentor would then liaise with the participants’ clinic for follow-up. CATS additionally supported caregivers with information and counselling. Participants requiring referral for other services, such as social welfare, were identified through support group or home visits, and were referred accordingly. All nine CATS attended a weekly feedback meeting with the CATS Mentor at the clinic. Participants in the intervention arm were also encouraged to attend a support group, if they wished.
Data collection
The study utilised a questionnaire to collect quantitative data on the impact of the CATS intervention on self-reported adherence, psychosocial well-being and retention in care. The survey questionnaire was developed from previously validated questionnaires used in an earlier study among adolescents living with HIV enrolled in the Zvandiri programme [12]. Data collection involved a questionnaire administered at baseline, which was then repeated at three, six, nine and twelve months for all participants, including those in the intervention and control arms.
Questionnaire
The questionnaire was comprised of five components, namely: demographic information; adherence; psychological well-being, and linkages and retention in care. The questionnaire was translated into Shona, the local language. Data was collected using printed questionnaires. There were 71 closed-ended questions on the survey, i.e. 9 questions on demographics, 16 questions on adherence, 36 questions on psychological well-being and 10 questions on linkage and retention in care. The first 11 adherence questions were on knowledge which used “2 = Yes” for those with adherence knowledge, “1 = a little”, “0 = No” for those without adherence knowledge and “99 = not applicable”. The last five questions on adherence, used “1 = Yes” and “0 = No”. The mental health sections had three sections namely; (i) confidence, self-esteem and self-worth and had a three-point Likert scale: “2 = Yes”, “1 = a little” and “0 = disagree” (ii) stigma and (iii) quality of life sections had a five-point Likert scale: “4 = strongly agree”, “3 = agree”, “2 = neutral”, “1 = disagree” and “0= strongly disagree”. The linkages to services and retention questions were answered using five options, “3 = very much”, “2=a moderate amount”, “1= a little” and “0=not at all”.
The questionnaire was pretested with 10 respondents in Gokwe in a separate health centre. Pre-testing assessed the understanding of procedures for administering questionnaires among adolescents living with HIV, as well as the validity and reliability of questions. As a result, some questions were simplified or omitted to prevent response bias.
Trained enumerators conducted data collection. The training familiarised the enumerators with the Zvandiri programme, background and justification for this study, objectives of the study, study methodology, ethical considerations and general research knowledge.
Data analysis
Data from the baseline, quarterly and twelve-month surveys was analysed using descriptive statistics (proportions, means or point system with 4 being highest while 0 was least) and odds ratios to provide evidence of effectiveness of the CATS intervention on improving linkages and retention, adherence and psychosocial well-being and linkages to health retention and care.
Ethical considerations
Ethics approval was granted by the Medical Research Council of Zimbabwe in 2014. Written informed consent was obtained from the caregivers of all participants, and participants were required to give assent prior to their participation in the study.