New and effective HIV prevention strategies are needed, especially those that can be delivered to and used by populations most at risk for HIV. The single addition of PrEP to the available services in existing programs is consistent with the World Health Organization’s (WHO) recommendation to conduct PrEP demonstration projects within the local country context. This approach will provide data on safety, tolerability, acceptability and adherence in real world settings, data which are required for understanding the potential effectiveness, and utility, of PrEP as a public health intervention.  Integration into existing programs will also provide critical data to the Kenya Ministry of Health on this model of service delivery.

 

In this open-label, prospective study, 500 participants will receive Truvada (emtricitabine and tenofovir disoproxil fumarate) at two study sites in Kenya. Detailed information on Truvada for PrEP will be given to the participant and the participant will be counseled on HIV-risk reduction (according to existing program). Patient-centered and integrated counseling on HIV risk reduction and PrEP adherence will be conducted at enrollment and follow-up visits. STIs will be assessed and treated during visits per local clinical procedures.  

Study objectives are;

• Describe the patterns of adherence to a regimen of daily oral Truvada® among female sex workers currently or newly enrolled in established HIV prevention programs 

• Assess the feasibility of integrating PrEP into existing HIV prevention programs for female sex workers

The following secondary outcome measures will also be considered

• Describe self-reported and electronically-monitored patterns of adherence to a regimen of daily oral Truvada® among female sex workers currently or newly enrolled in established HIV prevention programs

• Assess the correlation between drug level adherence data and participant self-reported adherence data 

• Assess the impact of PrEP on HIV risk-taking behavior

• Identify factors associated with adherence to PrEP

• Assess impact of adherence support by peer educators on PrEP adherence

• Describe contraceptive use

• Assess resistance to TFV or FTC among seroconverters

Assess birth outcomes among women who choose to continue PrEP during pregnancy