Please go through each of the PRECIS-2 domains and give it an suggested or approximate score, and a few sentences on yours justification.
Amanyire
- Eligibility: 4, rather pragmatic. In the general, the inclusion criteria is very broad, but I didn’t give 5 given that those under 18 were excluded even though they would be eligible in for ART in the “real world.”
- Recruitment: 5, very pragmatic. In this study, randomization occurred at the clinic level, and patient were not individually recruited or enrolled in the study. This is a very pragmatic approach as those patients who became part of the study all came to the enrolled clinics of their own volition, and thusly were not recruited in any way and would not reflect a specialized population of those who are more likely to enroll in research.
- Setting: 4, rather pragmatic. The intervention was rolled out in the existing clinics operated by the Ministry of Health and supported by the Makerere University Joint AIDS Program. This existing infrastructure was use prior to study and reflects “usual care.” Only two clinics declined. It is unclear whether other HIV/AIDS care is provided in other types of clinics or centers; if not this would be very pragmatic, instead of rather pragmatic.
- Organization: 5, very pragmatic. As noted in the methods section, “all components of the intervention were existing (but not fully implemented)” in the clinics. No additional resource support needed.
- Flexibility: delivery: 4, rather pragmatic. The intervention included specialized training including clinical considerations and an introduction of a different counseling model via didactic sessions. Additionally, there were biannual feedback to the clinics to encourage implementation of the clinical recommendations.
- Flexibility: adherence: 4, rather pragmatic. It was not well described how the researcher ensure adherence to the intervention. In theory, because the intervention was the didactic session, there would be 100% adherence. But it is unclear if there were any attempts to measure implementation of the counseling methods, etc, other than measured ART initiation.
- Follow-up: 5, very pragmatic. The electronic medical record was used to assess for ART initiation at 14 days, 30 days and 90 days; as well as viral load and survival at one year. It appears patients had routine usual care follow-up, with no additional follow-up needed specifically for the study.
- Primary outcome: 4, rather pragmatic. Primary outcome was ART initiation within 14 days of clinical eligibility. This is very easy to use in “usual care” settings and would be likely be important to patients. While not traditionally “patient-centered,” because of the known benefit of ART, early initiation would be of import to patients.
- Primary analysis: 4, rather pragmatic. Patients with less than 14 days of follow-up were excluded. It unclear if excluding all those, instead of just those without documentation of ART initiation would affect the analysis.
Rosen
- Eligibility: 2, rather explanatory. There many exclusion criteria; <18 years, pregnant, prior ART eligibility, those who stated they planned to seek care at another clinic in next 12 months, or deemed “physically or emotionally unstable.”
- Recruitment: 3, either pragmatic/explanatory. Not well described, but appears counselors were paid to refer patients to study assistant.
- Setting: 2, rather explanatory. There were two sites involved in the study. One of the sites was a large, hospital-based HIV clinic, representing a specialized institution, while the other clinical was a primary health clinic. Neither appeared to incorporate rural settings.
- Organization: 2, rather explanatory. There was additional study staff that had received specific training, but they had similar certification level as existing staff. However, the potential time intensive nature of the RIT protocol, it possible additional staff would be needed if implanted as usual care. Additionally, there was extra equipment, specifically the POC instrument.
- Flexibility: delivery: 4, rather pragmatic. One day visit for the intervention with specific components, but significant flexibility. However, it is likely quite time intensive and requires special equipment.
- Flexibility: adherence: 4, rather pragmatic. Those in the intervention group were able to complete the RIT protocol at another time within 30 days.
- Follow-up: 5, very pragmatic. “Patients who started ART in either arm received standard-of care treatment management from the clinic, which called for monitoring visits and medication refills at 1, 2, 3, 6, and 12 mo after initiation, with a routine viral load test at the 6 mo visit.” This was stand of care follow-up.
- Primary outcome: 3, either pragmatic/explanatory. The primary outcome was viral suppression, defined as <400 copies/ml, within 10 months of study enrollment. This outcome is not “patient-centered” in the traditional sense, but may be meaningful to patients due to changes in time to AIDS diagnosis or death, as well as transmission risk.
- Primary analysis: 4, rather pragmatic. Patients who were randomized but did not meet inclusion criteria were excluded from the primary analysis.