Trial Outcomes & Findings for Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique (NCT NCT03076359)

Last Updated: 2020-09-29

Results Overview

We accessed the percentage of days where participants have medication. For example, if a participant picked up a 30 day supply of medication on August 1st but did not collect their next medication until October 1st, the patient would only be considered retained for 50% of the time.

Recruitment status

COMPLETED

Study phase

Target enrollment

320 participants

Primary outcome timeframe

Retention in care over 12 months

Results posted on

2020-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Traditional Healer Support Program This group will receive standard of care as described above plus support from a trained traditional healer. The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. Traditional Healer Support Program: Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.	Standard of Care Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Overall Study STARTED	150	170
Overall Study COMPLETED	150	170
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=170 Participants Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.	Traditional Healer Support Program n=150 Participants This group will receive standard of care as described above plus support from a trained traditional healer. The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. Traditional Healer Support Program: Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up	Total n=320 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 11 • n=5 Participants	33 years STANDARD_DEVIATION 10 • n=7 Participants	33 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	75 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	75 Participants n=7 Participants	152 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	170 Participants n=5 Participants	150 Participants n=7 Participants	320 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mozambique	170 participants n=5 Participants	150 participants n=7 Participants	320 participants n=5 Participants
Employment	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Retention in care over 12 months

Population: Several patient ID numbers were not able to be matched to online database of patient records at this point give discrepancies in name or community. Given new paper records were introduced in 2019 we were not able to go back to the original records for cross-reference of medication pick-up.

Outcome measures

Outcome measures
Measure	Standard of Care n=163 Participants This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.	Traditional Healer Support Program n=113 Participants This group will receive standard of care as described above plus support from a trained traditional healer. The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. Traditional Healer Support Program: Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Retention in Care	80 percentage of medication coverage Interval 48.0 to 92.0	79 percentage of medication coverage Interval 57.0 to 90.0

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: While this was one of our primary outcomes, less than 50% of our patients had a viral load within 2 months of the end of their first year in treatment. Laboratory capacity and transportation issues have been a problem in rural Mozambique for many years. While we were hoping this would be solved before the end of our study it was not.

Patient viral load at 12 months to assess the impact of the intervention on HIV viral suppression. HIV viral load tests are reported as the number of HIV copies in a milliliter (copies/mL) of blood using a reverse-transcriptase polymerase chain reaction (RT-PCR) test. If the viral load measurement is high, it generally indicates that HIV is present and replicating. Initial, untreated, and uncontrolled HIV viral loads can range as high as one million or more copies/mL. Viral loads that are consistently less than 200 copies/mL indicate that the virus is adequately suppressed and that the risk of disease progression is low. Viral load results below zero indicate that no virus was detected (this is how the outputs are recorded using the PRC test in the region. We did not assess change in values over time.

Outcome measures

Outcome measures
Measure	Standard of Care n=75 Participants This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.	Traditional Healer Support Program n=37 Participants This group will receive standard of care as described above plus support from a trained traditional healer. The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. Traditional Healer Support Program: Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients. Standard of Care: First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Viral Load	-20 copies/mL Interval -20.0 to 1326.0	-20 copies/mL Interval -20.0 to 1037.0

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Traditional Healer Support Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Audet

Vanderbilt University

Phone: 615-343-2418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place