Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04036318
Other study ID # 16.02.PPT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2018
Est. completion date August 13, 2019

Study information

Verified date September 2020
Source National Institute for Medical Research, Tanzania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3022
Est. completion date August 13, 2019
Est. primary completion date August 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Tanzania Dar es Salaam region Dar es Salaam Temeke
Tanzania Shinyanga Region Shinyanga Kahama

Sponsors (1)

Lead Sponsor Collaborator
National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Associations between demographic, socio-economic, behavioral and biological risk factors, STI prevalence and PPT impact. The association will determined by using the logistic regression After six months of periodic presumptive treatment of STIs among FSW in Shinyanga
Secondary Changes in sexual risk taking behaviors while receiving PPT Changes in sexual risk behaviors will be determined by comparing the baseline prevalence and prevalence after six months of PPT Six months
Secondary Prevalence of cervical cancer lesions The prevalence of cervical cancer lesions, will be assessed through Visual Inspection with Acetic Acid (VIA), among the FSW in the study. Six months
Secondary Prevalence of Human Papilloma Virus (HPV), HIV, Hepatitis B and C The prevalence of Human Papilloma Virus (HPV), HIV, Hepatitis B and C will be assessed from the bio-specimens of serum and genital swabs collected during the surveys Six months
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2