CID 0911 - Adaptation of A Depression Treatment Intervention for HIV Patients in Cameroon

Patient registry only applicable to Specific Aim 3. This aim provided depression care management decision support to all depressed HIV patients who enrolled. There was no comparison arm. This study was an R34 feasibility study adapting measurement-based depression care to a low income sub-Saharan African setting, and Aim 3 assessed the logistics enrolling and monitoring patients.

(Per original protocol, which was followed) Specific Aim 3. Demonstrate the feasibility of recruiting and retaining patients over time and collecting and processing laboratory specimens.

In this aim the investigators seek to quantify objective measures of the feasibility of our planned RCT to assess the effectiveness of the MBC intervention on ART treatment outcomes in HIV patients in Cameroon. Specific measures will include percentage of eligible patients that consent to participate in the study, patient retention over 12 months, percentage of clinic visits and outcome interviews completed at each time point, and percentage of blood samples collected, tested and having valid results. These measures will be important in the quantification of the sample size needed for the definitive RCT. The investigators will also identify procedures that could hamper the successful implementation of the RCT and propose appropriate modifications.

Feasibility study: To achieve this aim the investigators will conduct a pilot prospective study with a sample of 60 participants. This study will begin during year 2 of the project and patients will be accrued over 4 months (15 patients per month) in order to allow for a smooth processing of participants and samples. Standard clinical care will be modified at Bamenda ATC so that the DCM will screen all newly presenting HIV patients for depressive symptoms with the PHQ-9. Patients scoring ≥10 on the PHQ-9 (or above an alternate threshold established in the validation study) will complete further evaluation with the DCM for presence of MDD. These patients will have their MDD confirmed by the HIV clinician. This two-stage screening procedure has been successfully applied by our team at rural medical clinics with low income patients.

The sampling frame for the feasibility study will consist of all patients who are HIV+, 18-55 years old, and have confirmed MDD. Patients will be excluded if they do not speak English well enough to complete the instruments or if they are not mentally competent to provide informed consent, as assessed by the medical team. As noted above, based on Dr. Atashili's clinical experience the investigators expect >95% of clinic attendees to be able to communicate effectively in English. Pregnant and breastfeeding women will not be excluded from the study but will be counseled regarding the particular risks and benefits of participation for them. AMI has the potential to adversely affect the developing fetus, primarily through its anticholinergic properties, although recent observational studies and systematic reviews indicate no increased risk of congenital malformations or developmental delays associated with AMI use. Further, because ADPs such as AMI are potent agents that act on the central nervous system, use by nursing mothers presents theoretical short and long-term risks to the infant's neurodevelopment. Infant behavioral monitoring before and after initiating treatment with the mother is clinically useful to monitor the effects of ADPs during nursing. Infants may exhibit short-term effects such as lethargy, poor weight gain, hypotonia and inconsolability, although the limited data available show that most infants of nursing mothers taking AMI doses consistent with our protocol have had no detectable AMI level. Potential neonatal effects must be weighed against the benefits to both mother and child of successfully treating a MDD. These issues and our related informed consent plans are discussed in detail in the Human Subjects Protection plan in the grant application.