Impact and Process Evaluation of Integrated Community and Clinic-based HIV-1 Control: a Cluster-randomised Trial in Eastern Zimbabwe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 9,454
- Locations
- 1
- Primary Endpoint
- HIV Incidence at the Community Level
Study Overview
Brief Summary
The purpose of this study is to determine whether community-based peer education and condom distribution combined with improved treatment of sexually transmitted infections are effective in reducing the spread of HIV infection in a sub-Saharan African population
Detailed Description
Background and Literature Review
The Spread and Early Demographic Impact of HIV in Zimbabwe
High levels of HIV prevalence and incidence have been recorded in Zimbabwe since sentinel surveillance was introduced in 1990. Prevalence levels in excess of 40% have been recorded among women attending antenatal clinics in a number of urban centres [1,2]. In a cohort study of male factory workers conducted in Harare between 1993 and 1995, 19% of participants were found to have the infection at enrolment and an incidence rate of 2.93% per annum was recorded [3]. However, rural areas - where 70% of the country's population are based - are experiencing some of the highest rates of incidence at the current time. In Mberengwa, Midland Province, HIV prevalence among pregnant women increased from under 8% in 1992 to 25% in 1994 [4].
In a study in two rural areas of Manicaland Province, we also found high levels of HIV infection at antenatal clinics in 1993-94 - 24% and 14%, at the growth points in the Honde Valley and the Rusitu Valley, respectively. Further data from the Honde Valley in 1996 indicate that incidence remains high (2-4%). Significant increases in adult and infant mortality and in orphanhood were recorded. The cause-specific and age-patterns of increase indicate that these are due primarily to HIV infections. Sexual intercourse with casual partners is common and condom use is low. In qualitative studies, high proportions of men, but relatively few women, reported recent casual partnerships. Mathematical model simulations indicate that this pattern of behaviour could explain the greater excess mortality that was recorded among males, given a recent - last 4-5 years - escalation of the HIV epidemic in rural areas. Other ulcerative and non-ulcerative sexually transmitted diseases (STDs) are common, but only 2% of respondents were aware that STDs can facilitate HIV transmission [5 8].
Mathematical model projections, based on our understanding of the predominant behaviour pattern and fitted to observed trends in HIV prevalence, also indicate that further increases in adult and early childhood mortality are to be expected. Results from these simulations and empirical findings from Uganda suggest that these increases will result in adverse indirect effects, including high proportions of children experiencing orphanhood and distortions in the age- and sex-distribution of the population [9,10]. These effects may be compounded by fertility change. Birth rates are declining in rural areas of Zimbabwe at present and the HIV epidemic may re-enforce this decline through changes in behaviour or underlying fecundity [11]. Women with HIV infection are reported as having lower fertility than other women in Ugandan studies [12] and results from our research in Manicaland indicate that behaviour changes which would tend to re-enforce the existing decline in birth rates may be beginning to occur [7].
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 54 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: Males aged 17-54 years; females aged 15-44 years at last birthday Residence: Slept in a household in the study areas on at least 4 nights in the last 30 days
Exclusion Criteria
- •Age: Males below the age of 17 years at last birthday or aged 55 years or above; females below the age of 15 years at last birthday or aged 45 years or above Residence: Did not sleep in a household in the study areas on at least 4 nights in the last 30 days
Arms & Interventions
Intervention arm
Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities
Intervention: Syndromic treatment of sexually transmitted infections (Procedure)
Intervention arm
Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities
Intervention: Systemic counselling for STI patients (Procedure)
Control
Standard of care
Intervention arm
Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities
Intervention: Peer education among commercial sex workers and clients (Behavioral)
Intervention arm
Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities
Intervention: Condom distribution and promotion (Behavioral)
Outcomes
Primary Outcomes
HIV Incidence at the Community Level
Time Frame: 3 years
Number of new infections occurring per 100 person-years of follow-up
Secondary Outcomes
- Self-reported Genital Ulcers(1 year)
- Self-reported Urethral or Genital Discharge(1 year)
- Percentage of Participants Reporting Cessation of Sexually Transmitted Infection Symptoms(1 year)
- Percentage of Participants Reporting More Than One Casual Partner in the Past 3 Years(3 years)
- Percentage of Participants Attending a Peer Education or Other Programme Meeting(3 years)
- Percentage of Participants Scoring 60% or Above on an Index of HIV/AIDS Knowledge(3 years)
Investigators
Simon Gregson
Professor of Demography and Behavioural Science
Imperial College London
