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.
研究组 & 干预措施
Enhanced Counseling
Women in the intervention arm receive: (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 focused 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.
干预措施: Enhanced Counseling (Behavioral)
Standard of Care
Women in the control arm receive the standard of care in terms of HIV counseling and testing during pregnancy. The standard of care for HIV counseling adheres to guidelines provided by the US Centers for Disease Control and the World Health Organization. Women receive one individual pre-test counseling session immediately before they are tested for HIV, and one individual post-test counseling session the same day that they are tested.
干预措施: Standard of Care (Behavioral)
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