Evaluation of Presumptive Periodic Treatment (PPT) of Sexually Transmitted Infections (STIs)

NCT04036318 | Completed

• 1 other identifier: 16.02.PPT
• Study Type: observational
• Target: 3,022
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexually Transmitted Diseases, Bacterial; HIV Infections

Keywords

Sexually Transmitted Infections; Periodic Presumptive Treatment

Outcome Measures

Primary Outcomes (2)

• Reduction of prevalence of laboratory confirmed bacterial STIs

  Reduction in prevalence of laboratory confirmed STIs (a combined measure of gonorrhea, chlamydia and Treponema pallidum) in men who have sex with men (MSMs) in Dar es Salaam and female sex workers (FSWs) in Shinyanga after six months of presumptive treatment of STIs (PPT).

  After six months of periodic presumptive treatment of STIs

• Reduction of prevalence of syndromic STIs

  Syndromic STI prevalence (Genital ulcers disease (GUD), Anorectal Syndrome (ARS), Urethral Discharge Syndrome (UDS), Painful scrotal swelling (PSS)) among male clients of FSW in Shinyanga mines (bridge population) after six months of availability of PPT to FSWs. initiation.

  After six months of periodic presumptive treatment of STIs among FSW in Shinyanga

Secondary Outcomes (4)

• Associations between demographic, socio-economic, behavioral and biological risk factors, STI prevalence and PPT impact.

  After six months of periodic presumptive treatment of STIs among FSW in Shinyanga

• Changes in sexual risk taking behaviors while receiving PPT

  Six months

• Prevalence of cervical cancer lesions

  Six months

• Prevalence of Human Papilloma Virus (HPV), HIV, Hepatitis B and C

  Six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Willing to give oral informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute for Medical Research, Tanzania: lead

Study Sites (2)

Shinyanga Region

Shinyanga, Kahama, Tanzania

Location

Dar es Salaam region

Dar es Salaam, Temeke, Tanzania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Anorectal swabs, Endocervical swabs and dry swabs from ulcerative lesions will be collected for the assessment of the bacterial sexually transmitted infections. In addition, swabs will be taken from urethral discharges in men. 5 milliliters of blood will be collected from each study participant assessment of viral infections such as HIV and viral hepatitis (HBV and HCV)

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial; HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Amani Shao, MD; MPH; PhD

  National Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: May 14, 2018
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD will be shared during the study closure
• Access Criteria: Will be determined by the funder and sponsor

Locations

TA (2)