Clinical epidemiology of Herpes Simplex Virus type two and the impact of interventions against sexually transmitted infections to reduce human immunodeficiency virus incidence in high risk women from gold mining communities in Tanzania

Completed

Conditions: Human immunodeficiency virus (HIV)
Infections and Infestations
Unspecified human immunodeficiency virus [HIV] disease

Registration Number: ISRCTN35385041

Lead Sponsor: ondon School of Hygiene and Tropical Medicine (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1305

Inclusion Criteria

1. Aged 16 to 35 years
2. HSV-2 seropositive
3. Not planning to leave study sites within next 24 months
4. No history of epilepsy
5. Able to understand aims and procedures of trial

Exclusion Criteria

1. Pregnant or planning pregnancy within next 24 months
2. HSV-2 seronegative or indeterminate
3. Breastfeeding at time of enrolment
4. History of epilepsy
5. Temporary visitor in study sites
6. Unable to give informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV acquisition study: <br>1. HIV incidence by treatment arm<br>2. Frequency of genital ulceration by treatment arm<br>3. Adherence to therapy<br><br>HIV-positive women at enrolment:<br>1. Prevalence and quantity (log copies/ml) of cervico-vaginal HIV-1 RNA shedding by treatment arm<br>2. Plasma viral load by treatment arm <br>3. Prevalence and quantity of cervico-vaginal proviral HIV-1 DNA shedding<br>4. Prevalence and quantity of cervico-vaginal HSV-2 DNA shedding<br>5. Adherence to therapy

Secondary Outcome Measures