GHWP Data Summary

GHWP COHORT SUMMARY

Section Title

Description

Source population

Women aged 18 years or more at high risk of HIV infection, involved in sex work (defined as receiving money, goods or other favours in exchange for sex) or employed in entertainment facilities, and living or working in and around Kampala. Women aged 15 to 17 years old were also included if found to be emancipated minors (i.e. catering for their own livelihood, being pregnant or having already children) or mature minors (having an STI or drug and/ or alcohol dependence.

Study Location

Kampala, Uganda

Study Period

April 2008 to December 2020

Protocol title

The Good Health for Women Project (GHWP): studies on the epidemiology and prevention of HIV and other diseases in a cohort of women involved in high-risk sexual behaviour and their male regular partners in Kampala.

Study design

A prospective cohort study with three monthly follow-up visits

Sponsors/Funders

European & Developing Countries Clinical Trials Partnership (EDCTP2), 2008-2012

The UK Medical Research Council (MRC), UK Department for International Development, and the US President’s Emergency Plan for AIDS Relief (PEPFAR), 2013-2020.

Implementing Institution

MRC/UVRI and LSHTM Uganda Research Unit

Background /Rationale

In 2008 the Good Health for Women Project (GHWP) located in Kampala, Uganda recruited the first cohort of Ugandan women involved in high-risk sexual behaviour with the aim of studying the epidemiology and dynamics of the HIV epidemic, conducting research on STIs and offering a platform for basic science, social science and future HIV intervention studies in this population.

Primary Objectives (2008-2012)

1.      To study the epidemiology of HIV and other STI in a cohort of women involved in high-risk sexual behaviour in Kampala and their regular male partners.

2.      To study the feasibility of setting up and retaining a cohort of women involved in high-risk sexual behaviour and to study their willingness to participate in future vaginal microbicide safety and effectiveness studies.

Secondary objectives (2013-2020)

1.      To continuously assess risk of women involved in high-risk behaviour in Kampala and surrounding areas for future HIV prevention intervention trials

2.      To study the overall social context of high-risk sexual behaviour in Kampala, to explore the nature of regular and casual partnerships of these women and to determine risk perception and risk behaviour among male regular partners.

3.      To study the virology and immunology of early HIV infection and of inter subtype dual infections, among women involved in high-risk behaviour in Kampala and their regular male partners, as part of the MRC/UVRI and LSHTM Unit’s basic science research.

4.      To evaluate the effectiveness of interventions that aim to a) reduce HIV acquisition or transmission and b) reduce HIV disease progression, among women involved in high-risk behaviour and their partners.

5.      To investigate risk factors for non-communicable diseases among high-risk women in Kampala and their male regular partners

Specific Aims

To study the current burden and incidence of HIV and other sexually transmitted infections.

Study Site and infrastructure 

The study clinic was first established in Kibuye which is a densely populated slum area in Southern Kampala. The clinic initially covered hotspots across Makindye divisions before expanding to include hotspots across Rubaga division of Kampala. The clinic was then strategically shifted to Mengo, a location that was convenient and accessible for study participants. The clinic offered reproductive health care, including syndromic management of STIs, family planning services, HIV counselling and testing (HCT), health education, counselling and referral for excessive alcohol use and gender-based violence and condom distribution. The project provided basic antenatal care services at the study clinic to make reproductive health services as complete as possible. Primary health care was also offered for the women, their regular male partners and their children under five.

Target Population

Women aged 18 years and older or emancipated/ mature minors, engaged in sex work (defined as receiving money, goods, or other favours in exchange for sex), or employed in entertainment facilities and living or working in Kampala

Eligibility criteria

Inclusion criteria:

1) Women of 18 years or above and their regular male partners of 18 years and above, or being a mature or emancipated minor

2)  Involved in occupational activities generally known to expose women to high risk for HIV/STI (such as working in bars, guesthouses and other entertainment places or being a male partner of such a woman).

3)  Living or working in Kampala and selected areas of Wakiso district

4) Willing and able to return for follow-up visits and study procedures (3-monthly)

5)  Willing and able to give written informed consent (literacy not required).

Exclusion criteria:

Women and men who opt out of HIV counselling and testing services provided by the clinic.

Recruitment and enrolment

Mapped hotspots, defined as areas with large numbers of women engaged in high-risk behaviour. These included: brothels, streets where sex workers are operating, entertainment facilities, guesthouses or lodges and local beer shops.

Community engagement and mobilization were conducted to reach the target population, local community members, local leaders, and stakeholders involved to explore the feasibility and acceptability of this project.

All women and men, who were eligible and willing to join the project were registered to attend their first clinic visit the same day and thereafter given an appointment card to attend the clinic every three months.

Initially, 1027 women were enrolled into the cohort between April 2008 and May 2009 (first cohort) and followed up every three months thereafter. From January 2013, however, there was continuous enrolment of participants until 2019 (~3500 in the second cohort).

Follow-up procedures

For both cohorts, identical follow-up procedures were administered. Enrolled women were asked to return for follow-up at the study clinic at 3-monthly intervals for the following procedures:

·         HIV counselling and testing

·         STI management using syndromic approach

·         Reproductive health assessment and family planning services for women

·         Sexual behaviour assessment

·         Screening for referral of male regular partners if not concluded

The following procedures were administered at longer intervals as follows:

·         Syphilis serology (6 monthly)

·         Alcohol use disorder assessment (once a year)

·         Risk assessment and re-screen for eligibility (once a year)

Data and specimen collection

Using interviewer-administered structured questionnaires, data were collected on socio-demographics and economic status, sexual risk behaviour, alcohol and illicit drug use, intravaginal practices, reproductive health, STI symptoms.

Key findings

Data showed relatively high HIV seroprevalence of 37% among women at high risk (about 3 times that of the general population women from Kampala, 12%). HIV incidence dropped substantially with follow-up, particularly during the first three years of follow-up (2008-2010), reflecting the likely impact of the interventions provided through a dedicated clinic and targeted services. 

The prevalence of Neisseria gonorrhoeae was 13%, Chlamydia trachomatis, 9%; Trichomonas vaginalis, 17%; bacterial vaginosis, 56% and candida infection, 11%.  Eighty percent had herpes simplex virus 2 antibodies (HSV-2), 21% were TPHA-positive and 10% had active syphilis (RPR_TPHA_). In 3% of the genital ulcers, Treponema pallidum (TP) was identified, Haemophilus ducreyi in 6%, and HSV-2 in 35%. Prevalent HIV was independently associated with older age, being widowed, lack of education, sex work as sole income, street-based sex work, not knowing HIV-status, using alcohol, and intravaginal cleansing with soap. HIV infection was associated with N. gonorrhoeae, T. vaginalis, bacterial vaginosis, HSV-2 seropositivity and active syphilis.

Impact and publications

Findings showed that women working in entertainment facilities and self-reported sex workers were equally at high risk of HIV, identifying an urgent need to targeted interventions. Participants who regularly missed the 3-monthly scheduled visits were observed with a higher risk of HIV infection and reflected a need for approaches to reach these women at high risk at their places of work.