Table 4.
PRECIS-2[23] scores for trial domains.
| Domain | Score | Rationale |
|---|---|---|
| Eligibility Criteria | 4/5 | Eligibility criteria for club referral in the study, other than those related to the intervention, are based on criteria used in usual care including VL < 400 copies/ml and the absence of comorbidities requiring regular clinical follow-up. In routine services, patients on ART for <6 months are ineligible. As part of the intervention, we referred women in the immediate postpartum period, and reduced the required duration on ART to ≥3 months to accommodate women started on ART in pregnancy. |
| Recruitment path | 4/5 | Potential participants were approached at routinely scheduled service visits at the facility. While we had specific study recruiters who engaged with patients, no additional effort was made to engage patients. |
| Setting | 5/5 | Patients were referred to obtain HIV care at the routine service ACs or routine ART clinics, with no changes made to these systems. |
| Organisation intervention |
5/5 |
Patients are incorporated into routine AC club and clinic systems upon referral; no additional resources or organisation of care delivery are required. |
| Flexibility of experimental intervention – Delivery | 5/5 | The intervention is administered as part of routine services and flexibility for study and other patients is identical. |
| Flexibility of experimental intervention - Adherence | 4/5 | Flexibility for participants and routine patients attending the ACs is identical and follows standard guidelines: participants randomised to ACs may be referred to the general ART clinic for clinical reasons or due to visit non-attendance. In addition, those randomised to the ART clinic may be referred to ACs should they become eligible. For ethical reasons, study participants who attend study visits and are found to have defaulted ART are counselled to return to care and are given a referral letter. |
| Follow-up | 4/5 | Follow-up visits are 1–2 monthly at clinics and 2 monthly at ACs. Study follow-up is less frequent (at 3, 6, 12, 18 and 24 months), in order to minimise effects on adherence and retention. |
| Outcome | 5/5 | The primary outcome is based on VL measurement and is relevant in practice: it indicates effectiveness of ART and risk of HIV transmission and is used to make decisions regarding treatment failure and possible virologic resistance in routine care. |
| Analysis | 5/5 | The primary analysis will be intention to treat. |
AC: Adherence club; ART: Antiretroviral therapy; PRECIS-2: PRagmatic-Explanatory Continuum Indicator Summary 2; VL: Viral load.