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Completed

NCT Number: NCT03832530

Periconception PrEP for HIV-exposed Ugandan Women

In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies among Ugandan women exposed to HIV.

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Key information

Conditions

HIV Prevention

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara University of Science and Technology

Mbarara, Uganda

About this study

The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The primary outcomes are to evaluate uptake of and adherence to periconception PrEP among HIV-exposed women in rural Uganda.

To accomplish this, women will participate in quarterly study visits, HIV and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. Participants will be eligible to initiate PrEP at any time during the first 6 months of the 9-month study follow-up period. Participants who initiate PrEP will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV at quarterly study visits.

For women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.

Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .

Investigators will offer objective sexually transmitted infection (STI) testing to all participants in order to measure the prevalence, incidence, and factors associated with STIs. Investigators will compare incidence among women who choose and who do not choose PrEP. Investigators will also measure the number of episodes of condomless sex each month as a mediator variable for STI development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Self Report Inclusion Criteria:

  • Female
  • Aged 18-35
  • Likely to be fertile based on reproductive health history [55]
  • Reported personal or partner desire to have a child in the next year [56-59]
  • With a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed).
  • Live within 60km of clinic. Not planning on relocating to an area incompatible with ability to attend quarterly clinic over a 9-month follow-up period

Objective Inclusion Criteria:

  • HIV-negative (onsite rapid testing)
  • Not currently pregnant (onsite urine b-hcg testing)
  • Fluent in English or local language
  • Otherwise able to participate in the informed consent process

Exclusion criteria

  • Currently pregnant
  • HIV-positive

Treatment and study plan

Safer conception counseling inclusive of periconception PrEP

Behavioral

Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).

Primary outcomes

  1. Uptake of PrEP

    Time frame: 9 months

    Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception

Secondary outcomes

  1. Adherence to PrEP, daily pill taking behavior

    Time frame: 9 months

    We will measure the proportion of women who achieve daily adherence to at least 80% of PrEP through electronic pill count measurement

  2. Adherence to PrEP, plasma levels

    Time frame: 9 months

    We will measure the proportion of women who achieve TFV plasma levels consistent with taking medication (detectable) and taking enough medication to confer protection (=>40ng/mL).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Mbarara University of Science and Technology

Registry information

Official study title

Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 6, 2019
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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