Intravaginal practices in Tanzania and Uganda: Relationships with the vaginal microenvironment, HIV and other STIs

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

The human immunodeficiency virus (HIV) infects 25 million people in sub-Saharan Africa ? roughly two-thirds of the HIV infections worldwide. The greatest burden is shouldered by 13.3 million African women, who make up 60% of the epidemic in this region. Heterosexual intercourse continues to be the main mode of transmission, and there is strong evidence that some sexual behaviours can increase the risk of HIV infection. We are interested in looking at one set of common female behaviours called intravaginal practices to see if these might be a risk factor for HIV.

Intravaginal practices (IVP) involve putting something inside the vagina to clean, dry, or tighten the vagina. Scientists are concerned that these behaviours may cause tiny cuts or swelling in the vagina that could increase the risk of HIV infection. So far, studies have shown that many women in Africa use these practices, but the evidence linking IVP to HIV risk is still unclear. Studies have also shown that these practices are very different from community to community, and this makes looking at the HIV risk very difficult. Studies must carefully define IVP in each community, so that they can accurately link it to HIV infection.

Working with our collaborative partners in Africa, we have designed a multi-disciplinary study to see if IVP is a risk factor for HIV infection. We will invite women who work in bars and other food and recreational facilities in the city of Kampala in Uganda and small towns in northwest Tanzania to join the study and they will be followed up for one year. The main point of this study is to measure the risk of HIV among IVP users, but it will also study the types of IVP and the reasons women use these practices. In addition, this study will use clinical observations and laboratory tests to look in detail at whether IVP causes swelling or small cuts inside the vagina. This holistic approach is important, because if there is an increased risk of HIV from IVP, we will be able to give clear information on why women are using these practices and how they affect the vagina. This could provide the foundation for programmes to encourage women to change their IVP behaviour and help decrease the risk of HIV.

Technical Summary

In sub-Saharan Africa, 60% of the HIV epidemic is shouldered by women. Research is needed to better understand potential risk factors for HIV infection among women. Intravaginal practices (IVP) are common in Africa and have been shown to be associated with HIV in some cross-sectional studies. The only two prospective studies investigating these behaviours in Africa have shown conflicting results. More prospective studies are needed to investigate the effects of IVP on HIV incidence.

The proposed IVP Study will be nested within a large microbicide feasibility study (FS) in Tanzania and Uganda. A total of 1500 HIV-negative women working in high-risk occupations will be recruited to the cohort and followed up every three months for 12 months. The study objectives are to 1) describe and quantify IVP use within the study populations; 2) measure the effect of IVP use on incident HIV infection; and 3) investigate the effect of IVP on the vaginal microenvironment. Two sub-studies will be carried out to investigate IVP behaviours in more detail and to examine causal mechanisms for IVP effects.

IVP-related questions will be developed, pre-tested and incorporated in the FS questionnaire. Cervicovaginal lavage specimens will be collected every six months and used to quantify levels of inflammatory cytokines (IL-1b, IL-RA, IL-6, IL-8, TNF-a and TNF-Receptor II) and inflammatory leukocytes. Tests will be carried out for vaginal flora changes (bacterial vaginosis, Candida overgrowth) and sexually transmitted infections (STIs). The association of IVP with HIV incidence will be investigated, controlling for potential behavioural and biological confounding factors. Further analyses will explore the association between IVP, biomarkers of inflammation, BV and other STIs.

In the Coital Diary and Interview Sub-study, a 10% sample of women from the FS cohort will be asked to complete coital diaries daily for six weeks. In-depth interviews of these women will be conducted to explore the nature and sociocultural context of IVP in more detail.

In the Colposcopy and Inflammatory Biomarker Sub-study, 80-100 women from the FS cohort will be selected on the basis of their reported IVP behaviours, with over-sampling of behaviours assumed to carry higher risk. This sub-cohort will be followed up three times per week for four weeks to investigate short-term variations in inflammatory biomarkers and their association with different IVP behaviours. Colposcopic examination will be carried out at the first and last visits, and associations between IVP, colposcopic findings, BV and inflammatory biomarkers examined.

Publications

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Jespers V (2011) Methodological issues in sampling the local immune system of the female genital tract in the context of HIV prevention trials. in American journal of reproductive immunology (New York, N.Y. : 1989)

 
Description EDCTP - Clinical trials/capacity building grants (Characterisation of novel microbicide safety biomarkers in East and South Africa)
Amount € 2,688,595 (EUR)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 03/2009 
End 12/2012
 
Description EDCTP - Clinical trials/capacity building grants (Site preparation and capacity strengthening for trials of vaginal microbicides in Tanzania and Uganda)
Amount £2,000,000 (GBP)
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start  
 
Description IPM - Project Grant (Biomarkers for Microbicide Development)
Amount £84,021 (GBP)
Organisation International Partnership for Microbicides (IPM) 
Sector Charity/Non Profit
Country United States
Start 07/2009 
End 06/2011
 
Description MRC Population Health Scientist Fellowship (Bacterial vaginosis among women at high risk for HIV in East Africa: the role of behaviour, host immunity and the microbiome)
Amount £552,071 (GBP)
Funding ID G1002369 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 07/2011 
End 06/2015
 
Title Leukocyte Morphology Slide 
Description A smear of the cell pellet of the cervicovaginal lavage specimen. The smear is prepared similarly to a blood film, fixed with methanol, stained and read by a technician proficient in doing manual differentials. The technician records the type and count of white blood cells present in the smear. 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact Currently undergoing evaluation. 
 
Title Vaginal Practice Pictoral Diary 
Description Pictorial data collection tool in which participants record their vaginal practice and sexual history daily. 
Type Of Material Data analysis technique 
Provided To Others? No  
Impact Submitted paper to Sexually Transmitted Diseases "Vaginal practices diary: development of a pictorial data collection tool for sensitive behavioural data" 
 
Description EDCTP Biomarkers 
Organisation Institute of Tropical Medicine Antwerp
Country Belgium 
Sector Academic/University 
PI Contribution This is a collaboration between nine partners. The research collaboration has helped to develop new laboratory techniques for the Tanzanian National Institute of Medical Research in Mwanza.
Collaborator Contribution Training of staff in laboratory techniques Testing of samples for vaginal flora species by PCRTraining in laboratory techniques Testing of samples for vaginal flora species by PCR
Impact Training of staff in laboratory techniques. Samples for vaginal flora have been sent to two partners (ITM and University of Ghent), where they have been tested. Update Nov 2013: Results have been presented at 3 closed meetings and publications are being written and reviewed.
Start Year 2009
 
Description EDCTP Biomarkers 
Organisation University of Ghent
Country Belgium 
Sector Academic/University 
PI Contribution This is a collaboration between nine partners. The research collaboration has helped to develop new laboratory techniques for the Tanzanian National Institute of Medical Research in Mwanza.
Collaborator Contribution Training of staff in laboratory techniques Testing of samples for vaginal flora species by PCRTraining in laboratory techniques Testing of samples for vaginal flora species by PCR
Impact Training of staff in laboratory techniques. Samples for vaginal flora have been sent to two partners (ITM and University of Ghent), where they have been tested. Update Nov 2013: Results have been presented at 3 closed meetings and publications are being written and reviewed.
Start Year 2009
 
Description EDCTP microbicide trial site preparation and capacity strengthening in Tanzania and Uganda 
Organisation MRC/UVRI Uganda Research Unit on AIDS
Country Uganda 
Sector Public 
PI Contribution Similar questions about vaginal practices were included in the Tanzanian and Ugandan cohorts. A Diary Sub-study was carried out in both Tanzania and Uganda using a similar diary and study design.
Collaborator Contribution Contribution of data
Impact Social Science: Two if three joint social science papers have been published. The 3rd is in peer review with Social Science & Medicine. Epidemiology: The main joint results paper is in co-author review
Start Year 2006
 
Description IPM Biomarkers 
Organisation St George's University of London
Department Department of Cellular and Molecular Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Providing samples for testing of novel proteins
Collaborator Contribution Testing of samples for novel proteins
Impact These data have been presented at three closed meetings and publications are now being prepared.
Start Year 2007
 
Description Institute of Tropical Medicine 
Organisation University of Liverpool
Department Institute of Translational Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Grant holder for EDCTP grant: Preparing for clinical trials of interventions to improve the reproductive health of adolescent girls in sub-Saharan Africa.
Collaborator Contribution Oversight and coordination of project
Impact Project currently in progress
Start Year 2012
 
Description NIMR Mwanza Centre 
Organisation National Institute for Medical Research, Tanzania
Department Mwanza Intervention Trials Unit (MITU)
Country Tanzania, United Republic of 
Sector Public 
PI Contribution Technical (epidemiological, statistical, clinical, research) and administrative support.
Collaborator Contribution Providing laboratory and logistical infrastructure and support.
Impact Strengthening research capacity in Africa; scientific publications; joint research grants
 
Description Dissemination to health officials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact This meeting was held in Shinyanga among health officials

N/A
Year(s) Of Engagement Activity 2011
 
Description Dissemination to local officials 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Policymakers/politicians
Results and Impact Three meetings were held for local officials in each of the study sites in Kahama, Shinyanga and Geita.

N/A
Year(s) Of Engagement Activity 2010
 
Description Dissemination to participant meetings 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact Three meetings were held: two in Kahama sites and one in Geita sites.

N/A
Year(s) Of Engagement Activity 2010
 
Description National Dissemination Meeting in Tanzania 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact This meeting was held at NIMR Headquarters in Dar es Salaam on 01 February 2011.

N/A
Year(s) Of Engagement Activity 2011