PARTNERS IN HEALTH AND RESEARCH DEVELOPMENT (PHRD)

Experience

PHRD was established in 2006, as the Partners Study Clinic and has been involved in clinical trials research with a bias towards infectious diseases. Below are some of the clinical trials conducted at the site;

1. Phase III Randomized Placebo Controlled Trial Of HSV-2 Suppression To Prevent HIV Transmission Among HIV Discordant Couples. Also called the Herpes Study.

The objective of this study was to measure the efficacy of twice daily acyclovir suppressive therapy in preventing HIV transmission among HIV discordant couples.

Funding: Bill and Melinda Gates Foundation
Study period: June 2006 – October 2008
Study status: Completed, published
Participant numbers:
Pre-screened: 580 discordant couples
Screened: 477 discordant couples
Enrolled: 213 discordant couples
Retention: 97%
Adherence: 97%


2. Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV_1 Discordant Couples. Also called the Partners PrEP Study.

The objectives of this study are to determine the efficacy and safety of once-daily oral PrEP with TDF or FTC/TDF in preventing HIV-1 acquisition among HIV uninfected persons within HIV discordant couples.

Funding: Bill and Melinda Gates Foundation
Study period: October 2008 – 2013
Study status: Completed, published
Participant numbers:
Screened: 796 HIV discordant couples
Enrolled: 496 HIV discordant couples
Retention: 90%
Adherence: 96%


3. Ancillary Study of Genital Mucosal Sampling among Female Participants in the Partners PrEP Study

This study aims to determine levels of tenofovir in blood and mucosal tissues and to evaluate markers of innate and humoral immune response in mucosal tissues of HIV-1 uninfected individuals receiving oral tenofovir or emtricitabine/tenofovir versus placebo and in HIV-1 infected individuals.

Funding: Bill and Melinda Gates Foundation
Study period: October 2011 – 2013
Study status: Completed, analysis on-going
Participant numbers:
263 participants


4. Evaluation of Safety and Immunogenicity of GARDASIL in Healthy Females Between 9-26 years of Age in Sub Saharan Africa.


The aim of this double blind study is to observe the safety, tolerability and immunogenicity of a 3-dose regimen of Gardasil in healthy Sub-Saharan African females.
Funding: Merck & Co., Inc.
Study period: April 2011 – 2013
Study status: Enrollment complete, Follow up on-going
Participant numbers: 90 participants
Retention: 100%


5. Immunogenicity and Safety of quadrivalent HPV vaccine in HIV-infected pre-adolescent girls and boys in Kenya.

This study aims to assess the immunogenicity, safety and tolerability of quadrivalent HPV vaccine among HIV infected boys and girls aged 9-14 years. In addition, the study will correlate the immune response to the vaccine with the degree of immunosuppression among the participants.

Funding: Merck Investigators Study Program
Study period: Q2 2013 – 2014
Study status: Enrollment Ongoing
Participant numbers: 180 participants (100 girls , 80 boys)
Retention: 100%


6. A randomized, open-label, crossover trial of the effect of high-dose daily HSV-2 suppressive therapy on plasma HIV-1 levels among HIV-1/HSV-2 co-infected persons. Also called the Val Study

The objectives of this study are to evaluate the effect of high-dose HSV-2 suppressive therapy using daily Valacyclovir 1.5 gram orally twice daily compared with standard dose acyclovir 400 mg orally twice daily on plasma HIV-1 RNA levels. In addition the study will evaluate the safety of Valacyclovir 1.5 gram orally twice daily in HIV-1 seropositive persons.
Funding: Bill and Melinda Gates Foundation
Study period: March 2010 to November 2010
Study status: Completed, published
Participant numbers:
Screened: 66 participants
Enrolled: 32 participants
Retention: 99%
Adherence: 98%


7. Cervical dysplasia and HPV persistence in HIV-positive and -negative African women. Also called the HPV Study.

The objectives of this study are to determine the incidence and prevalence of high-grade cervical dysplasia and carcinoma in a cohort of HIV-infected and demographically similar HIV-negative African women prospectively followed for up to 3 years. We shall also compare the outcomes of treatment of incident and prevalent cervical dysplasia in HIV-infected and HIV-negative African women. The frequency, type distribution, and persistence of HPV infection in HIV-infected and HIV-negative African women will also be determined. This is an ancillary study of the Partners PrEP Study.

Study period: The duration of Partners PrEP
Study status: Completed, data analysis on-going
Participant numbers: 463 women enrolled in Partners PrEP Study

8. Assessment of feasibility of ART based HIV-1 prevention, fertility intentions and HIV-1 risk perception among HIV-1 discordant couples in Thika, Kenya


The objectives of this study are to determine the user perceptions of ART-based HIV-1 prevention in HIV-1 discordant couples and to determine whether self-perceived HIV-1 risk and fertility intentions correlate with HIV-1 risk behaviors. This study utilizes both qualitative and quantitative techniques.

Funding: NIH grant
Study period: February 2011 – 2013
Study status: Completed, analysis on-going
Participant numbers: 816 participants - 4 FGDs, 27 In-depth interviews.

8. Investigation of Host Genetic Factors affecting HIV, HSV-2, other STDs and Viruses Interacting with HIV in the Partners in Prevention Study. Also called the Genetics Study.

The objectives of this study are to evaluate host genetic factors and their association with HIV infection, transmission and disease progression. The host genetic factors and their association with HSV-2 prevalent infection, transmission, recurrence and latency will also be evaluated. In addition we shall evaluate host genetic factors and their association with other sexually transmitted diseases and viruses. This was an ancillary study of the Herpes Study.

Funding: Bill and Melinda Gates Foundation
Study status: Follow up complete, sample analysis on-going


9. Phase III Randomized Placebo Controlled Trial Of HSV-2 Suppression To Prevent HIV Transmission Among HIV Discordant Couples – Additional Procedures at Unblinding Visit.


The objectives of this study are to compare sexual risk behavior, condom use, HIV acquisition and pregnancy rates before and after the Herpes Study. We also evaluated the genital ulcer outbreak after cessation of continuous suppressive therapy.

Funding: Bill and Melinda Gates Foundation
Study period: August 2009 – January 2010
Study status: Follow up complete, manuscript writing in progress
Participant numbers: 96 couples and 38 individuals


10. Promotion of Couples HIV Counseling and Addressing Barriers to HIV Disclosure and Willingness of Men to be Tested for HIV in Kenya.

The objective of this study was to document and understand the experience and benefits of couples with regard to HIV disclosure, the barriers to disclosure and men’s willingness to be tested for HIV by conducting systematic qualitative research. This documentation would be instrumental in the development of communication materials for advocacy and promotion of couple HIV counseling.

Funding: Kenya Free of AIDS (KEFA)  
Study status: Follow up complete, data analysis is on-going
Participant numbers: 48 participants and 8 Focus Group Discussions

11. Serological Response to Hepatitis B Vaccination: A Study of HIV Positive and HIV Negative Kenyan Adults. Also called the HBV Vaccine Study.

The objectives of this study are to determine the immune response to HBV vaccination (as measured by standard HBV surface antibody [HBsAb]) among HIV infected individuals and compare to HIV uninfected controls at completion of vaccination and 6 months post vaccination. We shall also determine factors associated with ameliorated response to HBV vaccine. This is an ancillary study of the Partners PrEP Study.
Funding: Bill and Melinda Gates Foundation
Study period: July 2009 – June 2010
Study status: Completed, published
Participant numbers: 150 participants

Research interests

The site has been involved in community engagement through establishment of Community Advisory Group (CAG), maintained networks with various community based organizations, opinion leaders and advocacy groups.

The clinical research site has established networks with the Ministry of Health and other partnering organizations. This facilitates recruitment of study participants from health facilities.

Disease areas

• HIV
• Sexually Transmitted Diseases (STDs)

Other information

Partners in Health and Research Development study Clinic is located in Thika town, Central Province. It is 40 km north of the capital city of Nairobi. The study house is on OAU Road, off Kenyatta Highway and is easily accessible by public means.