Horizons Projects | Operations Research Around the Introduction of Antiretrovirals in the Management of HIV-infected Individuals in Mombasa, Kenya

HORIZONS PROJECT
Operations Research Around the Introduction of Antiretrovirals in the Management of HIV-infected Individuals in Mombasa, Kenya

A pilot project was initiated in Mombasa to introduce highly active antiretroviral therapy (HAART) in public health facilities where a major concern is the ability of patients to adhere to strict medication schedules. Horizons researchers tested an innovative directly administered antiretroviral therapy (DAART) approach and compared it with the standard HAART approach in six health facilities through a prospective, randomized, controlled study. Researchers also documented changes in sexual risk behavior and in stigma and discrimination perceived and experienced by HIV-infected persons receiving HAART; and examined the costs and economic impact associated with antiretroviral introduction. Study partners included the International Centre for Reproductive Health, the Coast Provincial General Hospital, FHI/IMPACT, Management Sciences for Health RPM Plus, and the University of Ghent.

A total of 234 HIV-infected treatment-naive patients (DAART: 116 patients, non-DAART: 118 patients) were enrolled and all received a non-nucleoside reverse transcriptase inhibitor (NNRTI)-containing regimen. DAART patients received twice weekly observed medication and adherence support for 24 weeks, followed by routine monthly follow-up. Non-DAART patients received standard monthly follow-up. Follow-up was carried out at three treatment sites and six observation sites. Adherence was measured using clinic-based pill counts every month.

Interim results at 24 weeks indicate high adherence levels and statistically significant increases in mean CD4 counts for both groups. All patients showed a significant increase in mean body weight and a decline in depression scores. A significantly higher proportion of patients exposed to DAART consistently achieved greater than 95 percent adherence compared to those receiving standard care. The sexual risk behavior of patients on HAART was lower than that of patients on preventive therapy.

Patients were followed for an additional 24 weeks. Final results of the study are available.

Location

Mombasa, Kenya

Duration

May 2003–June 2007

Horizons and Population Council researchers

Avina Sarna, Johannes van Dam, Susan Kaai, Scott Geibel, Naomi Rutenberg

Non-Council collaborators

Bomu Mkomani Clinic

Kishor Mandaliya (Coast Provincial General Hospital)

Rick Homan (Family Health International)

Government of Kenya

Mark Hawken, Stanley Luchters (International Centre for Reproductive Health)

Likoni, Bamburi, and Magongo Health Centres

Management Sciences for Health RPM Plus

Ministry of Health

Marleen Temmerman (University of Ghent)

Port Reitz District Hospital

Donor

US Agency for International Development

Publications/Resources on this project

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