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临床试验/NCT00390949
NCT00390949已完成不适用

Impact and Process Evaluation of Integrated Community and Clinic-based HIV-1 Control: a Cluster-randomised Trial in Eastern Zimbabwe

Imperial College London1 个研究点 分布在 1 个国家目标入组 9,454 人开始时间: 1998年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9,454
试验地点
1
主要终点
HIV Incidence at the Community Level

研究概览

简要总结

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

详细描述

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].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 54 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Intervention arm

Experimental

Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities

干预措施: Syndromic treatment of sexually transmitted infections (Procedure)

Intervention arm

Experimental

Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities

干预措施: Systemic counselling for STI patients (Procedure)

Control

No Intervention

Standard of care

Intervention arm

Experimental

Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities

干预措施: Peer education among commercial sex workers and clients (Behavioral)

Intervention arm

Experimental

Peer education with female sex workers and potential male clients. Strengthened syndromic management of STIs with community-based promotion activities

干预措施: Condom distribution and promotion (Behavioral)

结局指标

主要结局

HIV Incidence at the Community Level

时间窗: 3 years

Number of new infections occurring per 100 person-years of follow-up

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Gregson

Professor of Demography and Behavioural Science

Imperial College London

研究点 (1)

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