Partners in Prevention: A Phase III Randomised Placebo-Controlled Trial of HSV-2 suppression to prevent HIV Transmission among HIV-Discordant Couples (known locally as Tshireletso Ya Balekane)
HIV/AIDS; HIV Prevention, STIs: Herpes Simplex Virus type II (HSV-2); genital herpes
Orange Farm, Johannesburg
Duration of Project
2005 – 2007
University of Washington
Bill & Melinda Gates Foundation via University of Washington
Dr Sinead Delany-Moretlwe and Dr Nkuli Mlaba
Project Aims /Objectives:
This study is a multi-centre randomised placebo controlled trial involving 3,000 heterosexual HIV-discordant couples in which the HIV infected partner also is infected with HSV-2 and has a CD4 cell count of at lease 250 cell/mm3 , from 14 sites across Africa.
The trial aimes to measure the efficacy of daily acyclovir suppressive therapy in preventing HIV transmission among heterosexual HIV-discordant couples in which the HIV-infected partner also has HSV-2 infection.
There are a number of secondary objectives aimed at estimating the per-contact HIV transmission probability and various factors associated with the risk of HIV transmission.
The RHRU is one of three South African sites involved in this trial.
Recruitment began in August 2005 and was completed in August 2006. Five hundred and twenty-five couples were counseled and tested for HIV and HSV-2, and 145 -(28%) were discordant. Seventy three eligible couples were enrolled in the trial.
HIV positive partners also infected with HSV-2 were randomised to receive either 400mg acyclovir or matching placebo. Each couple is followed up for a period of 12-24 months. HIV positive participants are seen on a monthly basis for risk reduction counseling and sipensing of study drug and condoms. At quarterly visits, couples are counseled together and the negative partner tested for HIV. All couples receive free condoms,STI treatment, treatment for genital herpes episodes, health education and referral to local services for HIV treatment. The last participant is expected to exit the study in August 2007.
The results of this trial are expected in 2008/9.
It is hoped that the study will provide evidence for whether daily treatment for genital herpes can prevent transmission of HIV from an infected person to an uninfected person, in the context of high levels of condom use.
- Introduction of couples HIV counseling and testing into a number of sites;
- Contribution to voluntary counseling and testing services in Johannesburg;
- Formation of a community advisory group to advise on implementation of research plan;
- Contribution to WHO guidelines on use of acyclovir for care of HIV+ persons;
- Research into issues concerning barriers to access to acyclovir in the public sector;
- Research into barriers in uptake of VCT in Orange Farm.
Further research into factors associated with HIV discordance in Orange Farm is planned. In additional, further research into the implementation and uptake of couples HIV counseling and testing in South Africa is planned.
If this trial is successful, there will be a need for operational research to inform the implementation of programmes to deliver HSV-2 treatment for high risk HIV positive individuals.
Projects in the STI's & HIV Research Cluster: