Clinical trial NCT04036318: Evaluation of Presumptive Periodic Treatment (PPT) of Sexually Transmitted Infections (STIs)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Diseases, Bacterial
HIV Infections
Keywords: Sexually Transmitted Infections
Periodic Presumptive Treatment
Lead sponsor: National Institute for Medical Research, Tanzania
Sponsor class: OTHER_GOV
First posted: 2019-07-29
Enrollment: 3022
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to reach men who have sex with men (MSM) in Dar es Salaam region and female sex workers (FSWs) in Shinyanga region both of which are representative of the population in Tanzania.

The study also is expected to have an effect on the bridging population in Shinyanga region. Bridge population in Shinyanga, are male mine workers who are considered to benefit from PPT provided to Female sex workers by Sauti program.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Willing to give oral informed consent
* 18 years of age or older
* Is referred from the pre-selected recruitment venues and present and recruitment card.
* Sexually active in the last 6 months
* At least half of self-reported monthly income is generated through sex work (FSWs only)
* Men who engage in sexual relations with other men regardless of the motivation (MSMs only)

Exclusion Criteria:

* Not willing to give informed consent
* Not sexually active in the last 6 months
* State of intoxication from recreational drugs or alcohol use or other reasons which would prevent voluntary and informed consent to the study as judged by investigator
* Pregnant women - (determined through pregnancy screening questions used by Sauti)
* Does not have a study referral card

Primary outcomes:
measure: Reduction of prevalence of laboratory confirmed bacterial STIs
timeFrame: After six months of periodic presumptive treatment of STIs
measure: Reduction of prevalence of syndromic STIs
timeFrame: After six months of periodic presumptive treatment of STIs among FSW in Shinyanga
Secondary outcomes:
measure: Associations between demographic, socio-economic, behavioral and biological risk factors, STI prevalence and PPT impact.
timeFrame: After six months of periodic presumptive treatment of STIs among FSW in Shinyanga
measure: Changes in sexual risk taking behaviors while receiving PPT
timeFrame: Six months
measure: Prevalence of cervical cancer lesions
timeFrame: Six months
measure: Prevalence of Human Papilloma Virus (HPV), HIV, Hepatitis B and C
timeFrame: Six months
Other outcomes:
Locations:
city: Shinyanga
country: Tanzania
facility: Shinyanga Region
state: Kahama
city: Dar es Salaam
country: Tanzania
facility: Dar es Salaam region
state: Temeke
Study officials:
affiliation: National Institute for Medical Research
name: Amani Shao, MD; MPH; PhD
role: PRINCIPAL_INVESTIGATOR
References: