Sexually Transmitted Diseases, BacterialPPTNCT04036318
Evaluation of Presumptive Periodic Treatment (PPT) of Sexually Transmitted Infections (STIs)
An observational study of Sexually Transmitted Diseases, Bacterial and HIV Infections, run by National Institute for Medical Research, Tanzania at 2 sites in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexually Transmitted Diseases, Bacterial, HIV Infections
- How many people
- 3,022 participants
- Where
- 2 sitesTanzania
- Study dates
- 14 May 2018to 13 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Dar es Salaam region
Dar es Salaam, Temeke
Shinyanga Region
Shinyanga, Kahama
About this study
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.
Read the 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.
- Keywords
- Sexually Transmitted Infections, Periodic Presumptive Treatment
- Medical subject headings
- Sexually Transmitted Diseases, Bacterial, HIV Infections, Sexually Transmitted Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
The association will determined by using the logistic regression
Measured: After six months of periodic presumptive treatment of STIs among FSW in Shinyanga
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
Measured: Six months
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.
Measured: Six months
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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start14 May 2018
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Diseases, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Amani Shao, National Institute for Medical Research, Tanzania
- Investigators
- Amani Shao, MD; MPH; PhD, Principal investigator, National Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036318
- Sponsor's protocol ID
- 16.02.PPT
- Acronym
- PPT
- Status last verified
- Sep 2020
- First submitted
- 25 Jul 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the open data policy, all data emanating from this study will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04036318
- Acronym / sponsor ID
- PPT / 16.02.PPT
- Keywords
- Sexually Transmitted Infections, Periodic Presumptive Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,022 participants (actual)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Study start
- 14 May 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction of prevalence of laboratory confirmed bacterial STIs
Time frame: After six months of periodic presumptive treatment of 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).
Reduction of prevalence of syndromic STIs
Time frame: After six months of periodic presumptive treatment of STIs among FSW in Shinyanga
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.
4 secondary outcomes
Associations between demographic, socio-economic, behavioral and biological risk factors, STI prevalence and PPT impact.
Time frame: After six months of periodic presumptive treatment of STIs among FSW in Shinyanga
Changes in sexual risk taking behaviors while receiving PPT
Time frame: Six months
Prevalence of cervical cancer lesions
Time frame: Six months
Prevalence of Human Papilloma Virus (HPV), HIV, Hepatitis B and C
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Yes. As part of the open data policy, all data emanating from this study will be shared with other researchers
Related trials for Sexually Transmitted Diseases, Bacterial
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amani Shao, MD; MPH; PhD principal investigator
National Institute for Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, Bacterial and HIV Infections, run by National Institute for Medical Research, Tanzania at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of prevalence of laboratory confirmed bacterial STIs (time frame: After six months of periodic presumptive treatment of STIs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.