HIV Infections Clinical Trial
Official title:
Evaluation of Presumptive Periodic Treatment (PPT) of Sexually Transmitted Infections (STIs) Among High-risk Populations Including Men Who Have Sex With Men, Female Sex Workers (FSW) and Mining Populations in Tanzania.
Sexually transmitted infections (STI) are important causes of reproductive health morbidity
and mortality, and have long been implicated as major co-factors in the sexual transmission
of HIV. Both ulcerative and non-ulcerative STI have been found to be strongly associated with
HIV in cross-sectional and prospective studies and hence STI prevention and care are
important aspects of HIV prevention.
Periodic Presumptive Treatment of STIS (PPT) where risk populations are presumptively treated
with a single dose of Azithromycin+Cefixime in regular intervals of 3 months has been shown
to be effective in reducing STI prevalence at population level and has recently been
integrated into the National STI guidelines of Tanzania. The USAID funded Sauti program will
be one of the first to implement these new guidelines and roll out PPT in high risk
populations in selected regions in Tanzania. This study will evaluate the impact of PPT as
delivered by the Sauti program on prevalence of STIs in men who have sex with men and female
sex workers in Dar es Salaam and Shinyanga respectively.
This intervention linked study evaluates the impact of PPT on population level in FSW and MSM
in Tanzania (Shinyanga and Dar es Salaam respectively). It is expected that PPT will reduce
laboratory diagnosed STIs by 50% in the population after a roll out of 6 months.
This evaluation uses a cross-sectional venue-based sampling design. Three rounds of cross
sectional data collection will be undertaken for MSM in Dar es Salaam and FSW in Shinyanga at
three months intervals (baseline, 3 months and 6 months). The change in prevalence will be
measured between baseline and 6 months assessments. The interim assessment will be used to
refine the sample size. Study participants will be recruited in venues frequented by FSW
(Shinyanga) and MSM (Dar es Salaam) in wards where Sauti operates. Respondents will be
continuously sampled from all venues until sample size is reached. In each round of data
collection, study participants will undergo physical examination, biological specimen
collection, laboratory and HIV tests and a questionnaire.
STI prevalence in MSM and FSWs will be measured during each survey and laboratory-confirmed
STI prevalence (gonorrhoea, chlamydia, syphilis) will be assessed.
Additionally, effect on STI prevalence in the bridge population will be measured by
retrospective analysis of routine data for the prevalence of syndromic STIs among the mining
population in Shinyanga, as collected in the context of the Sauti program mobile biomedical
services (CBHTC+), which will visit the major mines in Shinyanga prior PPT implementation and
after each survey. By the term major mines, we mean mines with large population of male mine
workers (between 1000-2000 male mine workers) at higher risk of HIV rather than mines with
modern mining infrastructure.
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