HIV/AIDS
Conditions
Brief summary
The overall goal of this project is to adapt and assess the impact of a traditional healer training program/intervention on the adherence, retention, and viral load of HIV infected patients newly initiated on anti-retroviral therapy in rural Mozambique.
Detailed description
Incorporating healers as anti-retroviral therapy adherence counselors can help reduce the crisis of HIV treatment abandonment. Healers are often accused of encouraging patients to abandon HIV care, but they can also serve as strong advocates for patient health. When healers were engaged as tuberculosis adherence counselors in South Africa, their patients were as successful as those supported by non-healer counselors. An innovative solution would be to engage trained healers as treatment partners to support medication and appointment adherence for people living with HIV. Healers are well positioned to address reported patient concerns, including: (1) keeping a patients HIV status a secret while providing support; (2) assisting with partner disclosure and initiating community/clinical systems of assistance if gender base violence is threatened/occurs; and (3) advocating for patients during clinical visits to ensure quality care is provided. Other programs in sub-Saharan Africa have shown that incorporating healers into an allopathic health system as adherence supporters for TB treatment is feasible, but healer use in HIV treatment is not well-documented. This novel intervention would provide patients newly initiated on ART a choice to nominate a specially trained healer as a treatment partner, and assess acceptability, feasibility, and patient outcomes using an interrupted time series quasi-experimental design. Community-based treatment partners can improve pharmacy adherence and loss to follow up , while decreasing stigma and isolation. Engaging healers to conduct counseling sessions in a community setting to improve ART adherence necessitates technical clinical and psycho-social training. The ART Adherence Support Worker Training program will be adapted and used to train healers to be quality treatment partners and advocates. The training will ensure healers have the knowledge and skills to effectively: (1) Educate people living with HIV about treatment and HIV care; (2) Assess serious medication side effects or HIV co-infections; (3) Counsel patients about safer strategies for partner disclosure (with assistance if needed); (4) Accompany the patient for each clinical appointment; and (5) Advocate for quality health care delivery when assisting each patient. The training team will conduct training of the healers. All patients initiating treatment will be screened for interest in having a healer treatment partner. Control and intervention patients will be followed for one year, allowing the investigators to compare outcomes at 12-months to study the effectiveness of healers as adherence partners.
Interventions
BEHAVIORALTraditional Healer Support Program
Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients.
DRUGStandard 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.
Sponsors
National Institute of Mental Health (NIMH)
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients: Individuals 18 years of age or older, HIV-infected, and newly enrolled in ART and treatment services at Namacurra Sede. * Traditional Healers: Healers will be eligible to participate if the healer lives within 10 km of the Namacurra Sede, received previous training from FGH, is 18 years of age or older, speak Portuguese, and see at least one patient per month
Exclusion criteria
* Patients: Individuals that are currently pregnant, HIV-uninfected, and/or not yet enrolled in HIV care. Individuals who cannot give consent due to mental limitations or intoxication. * Traditional Healers: Healers who believe they can effectively treat or cure HIV or other associated conditions will be excluded from the project.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Care | Retention in care over 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | 12 months post-enrollment | 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. |
Countries
Mozambique
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 170 |
| 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 | 150 |
| Total | 320 |
Baseline characteristics
| Characteristic | Standard of Care | Traditional Healer Support Program | Total |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 11 | 33 years STANDARD_DEVIATION 10 | 33 years STANDARD_DEVIATION 11 |
| Employment | 25 Participants | 21 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 170 Participants | 150 Participants | 320 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mozambique | 170 participants | 150 participants | 320 participants |
| Sex: Female, Male Female | 93 Participants | 75 Participants | 168 Participants |
| Sex: Female, Male Male | 77 Participants | 75 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 170 | 15 / 150 |
| other Total, other adverse events | 0 / 170 | 0 / 150 |
| serious Total, serious adverse events | 0 / 170 | 0 / 150 |
Outcome results
Primary
Retention in Care
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Retention in Care | 80 percentage of medication coverage |
| Traditional Healer Support Program | Retention in Care | 79 percentage of medication coverage |
Secondary
Viral Load
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Viral Load | -20 copies/mL |
| Traditional Healer Support Program | Viral Load | -20 copies/mL |