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

ISRCTN	ISRCTN35385041
DOI	https://doi.org/10.1186/ISRCTN35385041
Protocol serial number	066688
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funder	Wellcome Trust

Submission date: 22/07/2005
Registration date: 22/07/2005
Last edited: 06/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Deborah Watson-Jones
Scientific

London School of Hygiene and Tropical Medicine
Department of Infectious and Tropical Diseases
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2116
Email	deborah.watson-jones@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Double-blind randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	AMREF HSV Project
Study objectives	The main aim of this trial is to determine whether intervening against herpes simplex virus type 2 (HSV-2) using suppressive therapy with aciclovir will reduce the acquisition of human immunodeficiency virus (HIV) in HIV-negative women and whether suppressive therapy will reduce genital HIV and HSV viral shedding in women who are HIV-infected.
Ethics approval(s)	Ethics approval received from the London School of Hygiene and Tropical Medicine ethics committee and the Medical Research Coordinating Committee of Tanzania
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV)
Intervention	A double-blind, randomised, placebo-controlled trial of HSV-2 suppressive therapy with aciclovir 400 mg twice a day (bd), as a strategy to reduce HIV incidence, HSV-2 and HIV viral shedding. The trial is being conducted in a cohort of female bar, guesthouse and other recreational facility workers in goldmining communities and along truck-routes in NW Tanzania. Please note that this trial has extended follow-up to 30 months for first 1001 participants enrolled and enrolled another 304 participants who will be followed for 12 months. Therefore there is a new anticipated end date of 30th April 2007. The previous anticipated end date was 30/09/2006.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aciclovir
Primary outcome measure(s)	HIV acquisition study: 1. HIV incidence by treatment arm 2. Frequency of genital ulceration by treatment arm 3. Adherence to therapy HIV-positive women at enrolment: 1. Prevalence and quantity (log copies/ml) of cervico-vaginal HIV-1 RNA shedding by treatment arm 2. Plasma viral load by treatment arm 3. Prevalence and quantity of cervico-vaginal proviral HIV-1 DNA shedding 4. Prevalence and quantity of cervico-vaginal HSV-2 DNA shedding 5. Adherence to therapy
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1305
Key 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
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	30/04/2006

Locations

Countries of recruitment

United Kingdom
England
Tanzania

Study participating centre

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	10/04/2008	Yes	No
Results article	results	01/09/2009	Yes	No
Results article	results	01/05/2010	Yes	No