For more than 30 years, JHP has worked collaboratively with local and international government, community, academic and industry partners to conduct more than 50 clinical research studies. Topics have included the prevention, treatment and cure of HIV and other infectious diseases such as hepatitis, HPV, Covid-19, malaria, and tuberculosis. Our well-established infrastructure continues to support the research agendas of the following US NIH HIV/AIDS clinical trials networks, as well as non-network NIH research and several studies conducted with Jhpiego, BMGF and Merck/MSD.

1.  HIV Prevention Trials Network (HPTN)
2. Advancing Clinical Therapeutics Globally (ACTG)
3. International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT)
4. Microbicide Trials Network (MTN)
5. HIV Vaccine Clinical Trials Network (HVTN)
6. Covid-19 Prevention Trials Network (CoVPN)

The Direct Impact of Our Work on Health Policies and Practices

JHP has been fortunate to conduct and lead clinical trials that generated critical evidence to inform public health policy and practice in Malawi and globally. Examples from our completed studies include:

•  Advocacy for earlier access to treatment for people living with HIV, both for their own health and for their partners to stay uninfected (HPTN 052).
• Support for use of ART during breastfeeding to improve a mother’s health and reduce the risk of transmission to her baby (PEPI Study). The NVAZ and PEPI-Malawi trials provided useful data to corroborate findings from earlier studies on infant prophylaxis, and lent critical evidence to support the global ARV scale-up in antenatal clinics and labor wards.
• Identifying optimal drug regimens for the health and survival of mothers and babies living with HIV or exposed to HIV (IMPAACT 1077 PROMISE)
• Reassuring confirmation that the standard of care for TB screening and INH provision for TB preventive therapy, if implemented consistently and carefully, can and will reduce mortality even in patients with very advanced HIV disease. (ACTG 5274)
• The new HEPLISAV-B vaccine against hepatitis B was found to elicit a superior immunological response compared to the current standard of care vaccine, Engerix-B (ACTG 5379)
• The paradigm-shifting ACTG 5349 study demonstrated a profound advancement in the management of TB disease with shorter treatment courses. The 4-month regimen of rifapentine, isoniazid, pyrazinamide, and moxifloxacin (RPT-MOX) was safe, well-tolerated and non-inferior to the currently recommended 6-month regimen of rifampicin, isoniazid, ethambutol, and pyrazinamide.
• In a double-blind, double-placebo-controlled clinical trial ot long-acting cabotegravir (CAB-LA) compared to oral PrEP with Truvada, CAB-LA was 9-times more efficacious for the primary prevention of HIV-1 among women in sub-Saharan Africa, and a monumental step forward in the fight to control HIV incidence globally (HPTN 084).

The Blantyre site has also contributed to the development of establishing hematological and chemical pathology normal values among infants and their mothers. These findings are important in assessing adverse consequences of antiretrovirals in exposed populations of children and women.