SAHAPSEfficacy of HIV Posttest Support for ANC in South Africa
Enhanced Counseling
+ Standard of Care
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
Study start date: May 1, 2008
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location