Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02156622 |
| Other study ID # |
09-0852 |
| Secondary ID |
5R34MH084673-02 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 3, 2014 |
| Last updated |
June 4, 2014 |
| Start date |
July 2009 |
| Est. completion date |
November 2012 |
Study information
| Verified date |
June 2014 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Data and Safety Monitoring BoardUnited States: Federal GovernmentUnited States: Institutional Review Board |
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of this study is to adapt depression treatment intervention for HIV patients in
Cameroon. The PI will validate a depression severity measure, adapt key elements of the
intervention to the Cameroon context, train nurses and physicians to carry out the
intervention, and examine preliminary outcomes.
Participants: Aim 1: Hospital and clinic patients, visitors, health care workers. Aim 2: No
participants. Aim 3: HIV-infected patients. Procedures (methods): Survey instruments and ARV
treatment.
Description:
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.
Each day, the DCM will follow a random number algorithm to randomly select 12 patients from
the daily register of scheduled patients. The investigators expect this to be sufficient to
generate 4 eligible and consenting participants per week (assuming a 25% no show rate, 10%
prevalence of MDD and <20% refusal) or ~15 per month and will adjust it if needed in order
to meet recruitment goals. The DCM will assess eligibility and will invite eligible patients
to participate. Non-consenting patients will be asked their reasons for denial. All patients
with MDD (consenting or not) will be proposed a management plan by the DCM (as described
under Aim 2 above) which will be discussed with the treating physician. Participants will be
encouraged, to the extent they wish, to bring family members to appointments and to involve
their social support structure in their depression treatment plan. For consenting patients
the DCM will collect a whole blood sample to assess viral load ,CD4 count, and liver
function. These samples will be stored at -20o C and transported to the CSCCD laboratory to
be tested using standard procedures - VL using the automated Roche Amplicor assay of HIV VL,
and CD4 counts using flow cytometry. The DCM will issue a follow-up plan to each participant
and collect contact information (home address and phone number when available) to remind
patients of follow-up appointments. To assist patient and provider in balancing pregnancy-
and breastfeeding-related risks and benefits of AMI use, female participants will take a
urine pregnancy test at enrollment and annually thereafter as long as they remain on AMI.
Female participants who are not pregnant will be advised to discuss any plans for fertility
with their provider, and those not wishing to become pregnant will be counseled to either
avoid sexual intercourse or use contraception. Of note, all HIV+ patients at Bamenda are
strongly counseled to either practice abstinence or use barrier methods of protection during
sexual intercourse in order to avoid HIV transmission, with the secondary effect of avoiding
pregnancy.
Follow-up visits will be aimed at assessing the effects of both ARV and ADP treatment.
Assessment of depressive symptoms and ADP side effects will occur every 2 weeks until
remission and every 4 weeks thereafter. Assessments at weeks 12, 24, etc. will occur during
regularly scheduled clinic visits for ART prescription refills. Patients will return to the
clinic for additional in-person assessments at weeks 2, 4, and 8; assessments at weeks 6 and
10 will be conducted by phone when feasible or else in person. Based on Dr. Atashili's
experience with this patient population, the investigators expect approximately 50% of
participants to be reliably reachable by phone. Project funds will pay for additional clinic
visits required by the protocol. Critical decision points for potential modification of the
depression treatment plan (e.g., maintain dose, increase dose, or switch ADP) will occur at
weeks 4, 8, and 12 and will be informed by depressive symptom response and side effects as
described under Aim 2 above. Clinical assessment of HIV disease and blood samples for CD4
counts and viral load will be conducted at the visits at 4, 8 and 12 months of follow-up;
follow-up liver function tests will be performed based on clinical indication. Pregnancy
tests will be repeated annually. Patients will be counseled to avoid alcohol consumption,
and the DCM will clinically monitor alcohol use by asking patients at follow-up.
Separate from their ongoing contact with the DCM, participants will complete in-person
interviews at baseline and at months 4, 8, and 12 to assess self-reported general health,
ADP and ARV adherence, and sexual risk behavior. These in-person interviews will be
conducted by a CSCCD interviewer who is not a part of the participants' clinical care to
minimize the potential for social desirability bias. Interviews will be conducted in a
private location of the participant's choosing and will last ~30 minutes. General health
will be measured by the Medical Outcomes Study Short Form-8 (SF-8). Adherence for each
medication will be measured with four visual analog scale (VAS) items asking patients what
proportion of the time in the past month they have taken all of their medication doses;
taken more medication than prescribed; missed or skipped doses; and taken doses on time. VAS
adherence measures correlate well with other self-report measures of adherence and predict
virologic failure. Sexual risk behavior will be measured with questions asking participants
about the frequency of oral, anal, and vaginal sexual intercourse in the preceding 4 months,
separately by sex of the partner, by the partner's HIV status, and by whether a condom was
used. The interview will additionally include questions on age, sex, religious and ethnic
identification, educational attainment, and household income. Finally, the interview will
include questions about the acceptability of the intervention, including patients'
perceptions of the additional time cost imposed by the intervention as well as their
willingness and ability to purchase ADPs (current cost of <$1 per month) if the intervention
were part of standard clinical care rather than a research study.
As a second measure of adherence, the investigators will collect pharmacy records of the
quantity and date of all HIV and psychiatric medications dispensed to study participants
from a period starting 4 months before study enrollment to the end of follow-up. All
patients receiving HIV care at Bamenda ATC obtain their HIV medications at the hospital
pharmacy, which would also be the source for any ADP medications prescribed as part of this
study. Adherence will be calculated as the ratio of the number of days' supply of medication
divided by the days elapsed before the next refill. Adherence as measured by pharmacy
refills has been shown in other settings to be associated with virologic outcomes.
The DCM will attempt to contact patients who miss any visit by either calling the
participants when phone numbers are available or visiting the patient's home. The
investigators recognize that not all patients have phone numbers and that poor
identification (naming and numbering) of streets/homes will constitute a challenge for
identifying participants' homes. The investigators expect 50% of participants to have phone
numbers.
