HIV self-testing: breaking the barriers to uptake of testing among men and adolescents in sub-Saharan Africa, experiences from STAR demonstration projects in Malawi, Zambia and Zimbabwe.

Introduction: Social, structural and systems barriers inhibit uptake of HIV testing. HIV self-testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first-time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale-up in three African countries.

Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial.

In a microbicide safety and effectiveness trial (HPTN 035) in Malawi, 585 women completed the same questionnaire through a face-to-face interview (FTFI) and an audio computer-assisted self-interview (ACASI). Concordance between FTFI and ACASI responses ranged from 72.0 % for frequency of sex in the past week to 95.

The effect of human immunodeficiency virus and breastfeeding on the nutritional status of African children.

Background: The risk of HIV-1 infection is high among breast-fed children in sub-Saharan Africa. Monitoring the nutritional status can provide useful information to determine the effect of HIV infection and breast-feeding on child growth and development. We longitudinally assessed the nutritional status and determined its association with HIV infection and breast-feeding among Malawian children.

Fertility intentions of HIV-1 infected and uninfected women in Malawi: a longitudinal study.

This study aimed to determine changes in fertility intentions of HIV-1 infected and uninfected reproductive age women in Blantyre, Malawi. Participants were asked about their fertility intentions at baseline and at 3-month visits for 1 year. Time-to-event statistical models were used to determine factors associated with changes in fertility intentions.

The role of men in women's acceptance of an intravaginal gel in a randomized clinical trial in Blantyre, Malawi: a qualitative and quantitative analysis.

Survey questionnaires and focus group discussions were used to investigate the association between a female participant's acceptance and her perception of her male partner's acceptance of an intravaginal gel as a prototype microbicide. Women who perceived their male partners would accept using the gel were more likely to highly accept the gel as compared to women who perceived their male partners would not accept using the gel (OR=24.57; 95%CI: 16.

HIV-1 incidence among women of reproductive age in Malawi.

The aim of this study was to determine HIV-1 incidence among women of reproductive age in Malawi. A prospective study design was followed. HIV-1 uninfected women were followed up for nine visits during a period of 12 months.

Natural history and risk factors associated with early and established HIV type 1 infection among reproductive-age women in Malawi.

Background: Data evaluating the biological events and determinants of early human immunodeficiency virus type 1 (HIV-1) infection are limited in sub-Saharan Africa. We examined plasma viral levels and trends during early and established HIV-1 infection among reproductive-age women who participated in a randomized trial to treat genital tract infection in Malawi. We also assessed the association of injectable hormonal contraceptive use with HIV-1 infection.

Late postnatal transmission of HIV-1 and associated factors.

Background: The present study was undertaken to determine the risk and timing of late postnatal transmission (LPT) of human immunodeficiency virus type 1 (HIV-1).

Methods: Breast-fed infants previously enrolled in 2 trials of antiretroviral prophylaxis were monitored in Malawi. Kaplan-Meier and proportional hazard models assessed cumulative incidence and association of factors with LPT.

Intermittent intravaginal antibiotic treatment of bacterial vaginosis in HIV-uninfected and -infected women: a randomized clinical trial.

Objective: Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).

Design: Randomized, double-masked, placebo-controlled phase 3 trial.

Setting: Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.

The impact of breastfeeding on the health of HIV-positive mothers and their children in sub-Saharan Africa.

Objective: We assessed the impact of breastfeeding by women infected with human immunodeficiency virus (HIV)-1 on their morbidity and risk of mortality and on the mortality of their children.

Methods: We analysed longitudinal data from two previous randomized clinical trials of mother-to-child transmission of HIV conducted between April 2000 and March 2003 in the Republic of Malawi, Africa. Mothers infected with HIV, and their newborns, were enrolled at the time of their child's birth; they then returned for follow-up visits when the child was aged 1 week, 6-8 weeks and then 3, 6, 9, 15, 18, 21 and 24 months.

Haematological changes in African children who received short-term prophylaxis with nevirapine and zidovudine at birth.

We assessed the safety of short-term antiretroviral prophylaxis to prevent mother-to-child transmission (MTCT) of HIV by monitoring haematological changes in children up to the age of 18 months. Babies of HIV-infected women were randomised at birth to receive a single dose of nevirapine (NVP) alone or with zidovudine (ZDV) twice daily for a week. Based on the time of presentation to the labour ward, mothers of these babies might or might not have received intrapartum NVP.

Gender differences in perinatal HIV acquisition among African infants.

Objective: We investigated gender-specific risks of mother-to-child transmission (MTCT) at birth and at 6 to 8 weeks among infants born to HIV-infected African women.

Design: Follow-up study of infants enrolled in 2 randomized, phase III, clinical trials to prevent MTCT, conducted in Blantyre, Malawi, in southeast Africa.

Methods: Infants were enrolled at birth and monitored postnatally, and their HIV status was assessed at birth and at 6 to 8 weeks (assessment beyond 6-8 weeks is ongoing).

Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial.

Context: Antenatal counseling and human immunodeficiency virus (HIV) testing are not universal in Africa; thus, women often present in labor with unknown HIV status without receiving the HIVNET 012 nevirapine (NVP) regimen (a single oral dose of NVP to the mother at the start of labor and to the infant within 72 hours of birth).

Objective: To determine risk of mother-to-child transmission of HIV when either standard use of NVP alone or in combination with zidovudine (ZDV) was administered to infants of women tested at delivery.

Design, Setting, And Participants: A randomized, open-label, phase 3 trial conducted between April 1, 2000, and March 15, 2003, at 6 clinics in Blantyre, Malawi, Africa.

Short postexposure prophylaxis in newborn babies to reduce mother-to-child transmission of HIV-1: NVAZ randomised clinical trial.

Background: In sub-Saharan Africa, most women present late for delivery with unknown HIV status, which limits the use of intrapartum nevirapine to prevent mother-to-child transmission of HIV. We aimed to determine whether post-exposure prophylaxis of nevirapine plus zidovudine given to babies only reduced transmission of HIV more than did a regimen of nevirapine alone.

Methods: We randomly assigned 1119 babies of Malawian women with HIV-1 who presented late (ie, within 2 h of expected delivery) to either nevirapine alone or nevirapine and zidovudine.