In 2013, MHRP initiated a large, long-term cohort study at multiple African sites that evaluates HIV prevention, care and treatment services it supports through local facilities, funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).
AFRICOS, the first study of its kind in sub-Saharan Africa, takes place at sites in Kenya, Nigeria, Tanzania, and Uganda. Study participants are drawn from health facility clinic patient populations, allowing MHRP to monitor the impact of HIV-directed health and preventive services that fall under national guidelines.
“AFRICOS helps us capture the broader picture of the overall health of our HIV-infected patients,” said COL Julie Ake, M.D., the study’s lead investigator. “Researchers are gaining a better understanding of what leads to the best clinical outcomes, which in turn facilitates the sharing of best practices between sites.”
The ongoing study will recruit a total of 4,200 volunteers, including 3,500 HIV-infected and 700 HIV-uninfected adults and adolescents. The 15-year study is designed to collect retrospective data at enrollment, and participants will then be followed prospectively every six months.
Researchers are studying current national treatment regimens and long-term outcomes such as time to progression to AIDS and mortality. They also evaluate comprehensive demographics, social and behavioral risk factors and aspects of adherence. Another critical component is the collection of data regarding co-infections such as malaria and tuberculosis, as well as non-infectious co-morbidities such as cognitive decline and cardiovascular complications.
Broad primary objective: To longitudinally assess the impact of clinical practices, biological factors and socio-behavioral issues on HIV infection and disease progression in an African context.
- Evaluation tool for MHRP PEPFAR program
- HIV pathogenesis and impact of comorbidities
- Measurement of long term outcomes
Impacting Policies and Operations
AFRICOS findings are impacting HIV policy and PEPFAR programming, including evidence-based antiretroviral therapy (ART) recommendations. For example, AFRICOS provides important information on reasons for switching between ART drug regimens. Researchers found 45% of participants switched or stopped their first-prescribed ART regimen; top reasons for drug switching in change in Ministry of Health-supported regimen (28%) and insufficient supply ("stock-out," 23%) (Polyak, CROI 2019). Future research aims to evaluating underlying causes of stock-outs (i.e.: distribution failures vs. clinic ordering).
AFRICOS provides important clinical information on viral suppression, persistent low level viremia and drug resistance. Recently published findings showed that AFRICOS participants on failing ART regimens had a high burden of drug resistance that potentially limited the efficacy of standardized first- and second-line regimens. Therefore, researchers recommend reconsidering management strategies that emphasize adherence counseling while delaying ART switch because it may promote drug resistance (Crowell et al, 2020).
AFRICOS evaluates noninfectious comorbidities (NCDs), including cardiovascular risk factors, cognitive impairment, depression, TB and cervical cancer. Researchers found that NCDs are common; 38% of participants living with HIV have one NCD. 10% have two or more comorbidities, even though cohort is young (median age 38.5 years).
Most common NCDs were high blood pressure and cholesterol. MHRP Director Col. Julie Ake presented findings in 2020 that showed people taking dolutegravir-based antiretroviral treatment have a substantially higher risk of becoming overweight or obese compared to other people with HIV.
MHRP is enrolling volunteers at 12 HIV clinical treatment sites in four countries:
- Kayunga District Hospital
South Rift Valley, Kenya
- Tenwek Mission Hospital
- Kericho District Hospital
- Kapkatet District Hospital
- AIC Litein Mission Hospital
- Nandi Hills District Hospital
- Kapsabet District Hospital
- Kombewa County Hospital
- Mbeya Zonal Referral Hospital
- Mbeya Regional Referral Hospital
- Defense Headquarters Medical Centre, Abuja
- 68 Nigerian Army Reference Hospital, Lagos
MHRP developed a substudy mechanism that facilitates collaboration. For more information, or to inquire about collaborating on AFRICOS, please refer to our collaboration info sheet.
Protocol Chair: Col. Julie Ake, MD, MSc
Protocol Co-Chair: Dr. Christina Polyak, MD, MPH