HIV Self-testing for Partners of HIV-uninfected Postpartum Women

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan, legalább 30 hetes terhes, HIV-negatív nőket keres, valamint a férfi partnereiket, akiknek a HIV-státusza ismeretlen. A program az HIV önteszt és a PrEP igénybevételét segíti.

Életkor

18 év vagy idősebb, a nőknek és a férfiaknak is.

Nem

Nők és a férfi partnereik.

Biomarker vagy leletérték

Nők: nem reaktív (negatív) HIV-teszt a harmadik trimeszterben, amelyet a terhesgondozási lapon ellenőriznek.

A részvétel fő kizáró okai

• Súlyos pszichiátriai betegség, amely akadályozhatja a részvételt vagy a beleegyezés megadását, a vizsgálati csapat mérlegelése szerint

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.

A vizsgálat 2 csoportja

• H4P Intervention ArmMár használt kezelés, összehasonlításként

  At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution. In addition to what female participants in the control arm engage in, they will engage in 30-45 minutes HIVST and PrEP uptake counseling intervention at the baseline visit. Male partners, in addition to the SOC written information provided to the control arm, will also receive a QR code linked to a brief video created by the study team. The video will communicate, among other things, information on geographically diverse HIV treatment resources, and why linkage to HIV care is needed in the context of the relationship (e.g., increased risk for HIV during the postpartum period, risk of transmission to infant during breastfeeding, his role in protecting the family's health).

  Kezelés: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").

• Control ArmPlacebo, összehasonlításként

  At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will receive 15-20 minutes of counseling. Female participants will receive OraQuick Rapid HIV-1/2 Antibody Tests. OraQuick kits will include step-by-step instructions on use and interpretation of results. All female participants will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution and will engage in a brief exercise that involves evaluating the pros and cons of offering HIVST kits to their partners. All men will be provided with the HIVST kit by their female partners (including directions for use, consistent with SOC), along with a letter describing how to contact the study team.

  Kezelés: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").