Efficacy of HIV Posttest Support for ANC in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Incidence of sexually transmitted disease
研究概览
简要总结
This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women to examine the efficacy of an enhanced model of ongoing post-test support for women attending antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the intervention, the investigators will tailor voluntary counseling and testing (VCT) for HIV to the ANC setting and provide a continuum of psychosocial support for pregnant women through: (1) a standardized health education video before HIV pre-test counseling; (2) HIV pre- and post-test counseling sessions that prepare women for decisions related to testing, serostatus disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies for sexual risk behavior change; (3) two additional post-test counseling sessions postpartum focusing on legal education and referral, partner testing, sexual risk behavior change and family planning decisions and; (4) an active referral system to post-test support groups run by a clinically trained staff psychologist and (5) an active referral system to legal services run by a lawyer at the clinic.
Through this intervention trial the investigators will be testing the following hypotheses:
H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14 weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex since delivery.
H2: Women receiving the intervention will report significantly better outcomes related to prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months post-partum as compared to women in the control arm. PMTCT service uptake will be measured by acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs, adherence to national infant feeding guidelines, and family planning use among HIV-positive women.
H3: Women in the intervention arm will report significantly better psychosocial outcomes at 14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial outcomes will be measured by: perceived social support, emotional distress, and partner violence among HIV-positive and HIV-negative women.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible women:
- •are at least 18 years old,
- •are not pregnant,
- •have never tested for HIV or had most recently tested negative for HIV at least 3 months prior to recruitment,
- •report having a primary partner who they have been with for at least 6 months,
- •plan to live in Durban for at least the next year,
- •plan to take their infant to the clinic for immunization visits,
- •are able to communicate in English or Zulu, and
- •do not need critical care for a high risk pregnancy that clinic staff is unable to provide.
排除标准
- •Women are ineligible if they:
- •are younger than 18 years;
- •are not pregnant;
- •have previously tested positive for HIV;
- •do not have a primary partner defined as someone they have been with for at least 6 months;
- •are not planning to reside in Durban for the next one year;
- •are unable to communicate in English or Zulu;
- •require care for high risk pregnancy that can not be provided by the clinic staff.
结局指标
主要结局
Incidence of sexually transmitted disease
时间窗: 14 weeks post-partum
The investigators are using biologic markers of three STIs (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia). All women are tested for STIs at baseline and 14-weeks post-partum.
次要结局
- Condom use(14 weeks and 9 months post-partum)
研究者
Suzanne Maman
Associate Professor
University of North Carolina, Chapel Hill