ART Adherence, HIV, Linkage to Care, PMTCT, PrEP
Conditions
Brief summary
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who test and link to HIV care or prevention, compared to invitation letters for fast track testing. Pregnant women who are randomized to the arm with secondary distribution of HIVST to their male partners will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. The investigators will offer men confirmatory testing regardless of their HIVST result, counseling, and if negative, pre-exposure prophylaxis (PrEP) and if positive, antiretroviral therapy (ART). The investigators will provide counseling to minimize social harms of HIV self-testing, and additional counseling and referral to social support services when social harms occur. This project will address key challenges in PMTCT B+ programs, by evaluating innovative strategies to increase male partner's knowledge of their HIV status, disclosure, and involvement coupled with offering PrEP to HIV-negative men, ART to HIV-positive men, and encouraging post-partum ART continuation and adherence among HIV-positive women.
Detailed description
Uganda has the fifth highest HIV burden globally and one of the highest fertility rates in Africa. Prevention of mother-to-child HIV transmission Option B+ (PMTCT B+) is national policy in Uganda. To maximize the prevention and clinical benefits of PMTCT B+, the challenges of low HIV testing by male partners and high rates of post-partum discontinuation of ART, insufficient adherence, and incomplete viral suppression need to be addressed. Women may be more likely to continue ART long-term and have higher adherence post-partum if their partner is tested, there is mutual disclosure of HIV status, and their partner takes ART or PrEP, depending on his status. Innovative approaches are needed to allow men to test in settings other than busy antenatal clinics, preferably where they have privacy, are comfortable and do not miss work. Innovative HIV testing technology -HIVST- could increase male partner's uptake of HIV testing, and prevention (PrEP) or ART (for all HIV-positive men). This study has been designed to address this gap through an enhanced PMTCT B+ program with HIV self-testing, and linkage to PrEP or ART, for male partners. In a demonstration project the investigators recently completed among mutually disclosed East African HIV serodiscordant couples (the Partners Demonstration Project), integrated ART and PrEP delivery with time-limited PrEP for the HIV-negative partner as a 'bridge' until the HIV-positive partner was on ART for six months, and achieved viral suppression, was very acceptable, achieved very high uptake and adherence to ART and PrEP, and nearly eliminated HIV transmission. This protocol builds on that demonstration project by evaluating whether PMTCT outcomes are improved by increasing uptake of HIV testing and PrEP among HIV-negative men whose pregnant partner is HIV-positive. PrEP for HIV-negative male partners of HIV-positive pregnant women provides highly effective prevention benefits during an important 'season of risk' when men may have higher HIV acquisition risk from their partner if she is viremic (during the first few months after ART initiation, post-partum ART discontinuation or due to viral resistance), or from outside partners. The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women who are randomized to the HIVST arm, achieves higher uptake of their male partner's testing and linkages to HIV care and prevention among male partners, compared to invitation letters for fast track testing in the clinic (the standard of care). The investigators will recruit HIV-positive women ≥18 years accessing PMTCT B+ programs in Kampala, who have a male partner of unknown HIV status. Women will be randomized to the intervention (HIVST) or the control arm (invitation letters to deliver to partners to come for fast-track testing at the Antenatal Care (ANC) clinic where she receives care.
Interventions
BEHAVIORALHIV self-test kit
Women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.
BEHAVIORALStandard of Care (invitation letters for fast-track HIV testing in the clinic)
In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
Sponsors
National Institute of Mental Health (NIMH)
Harvard University
University of North Carolina, Chapel Hill
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eligibility For all participants * Able and willing to provide written informed consent * Able and willing to provide adequate locator information for study retention purposes For women * Age ≥18 * Currently pregnant * HIV-positive based on positive rapid HIV tests, according to national algorithm * Not currently enrolled in an HIV treatment study * Male partner not known to be HIV-positive or has not tested in the past 3 months For men - In partnership with an HIV-positive pregnant woman in PMTCT B+
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm | Up to 12 months post-partum | Evaluate whether the secondary distribution of HIV self-tests to enrolled male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV |
| The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm | Up to 12 months post-partum | Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of ART if they test HIV-positive. |
| The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm | Up to 12 months post-partum | Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of PrEP if they test HIV-negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing | Up to 12 months post-partum | Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with effective post-partum viral suppression among HIV-infected Uganda women. |
| The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners | Up to 12 months post-partum | HIV-infected pregnant women and their male partners, experiences, perspectives and views on HIV self-testing evaluated by an inductive content analytic approach conducted through qualitative interviews. This does not permit quantification of numbers of persons who endorsed particular themes. The main themes reported were 1. Women's fear about delivering HIV self-testing kits to their partner particularly if they had not previously disclosed their HIV status to their partner. 2. Variable strategies used by women to introduce HIV self-testing to their male partners. 3. Range of male partner responses to receiving an HIV self-testing kit. 4. Women's confidence in ability to interpret HIV self-test results for their partners. 5. Women's strategies to persuade their partners to link to HIV care or HIV PrEP. |
Countries
Uganda
Participant flow
Pre-assignment details
Data provided is for the women who were enrolled and randomized to the intervention of secondary distribution of HIV self-test kits to their male partner or standard of care delivery of invitation letter to their male partner to test for HIV at the clinic and for male partners who were consented later in the study.
Participants by arm
| Arm | Count |
|---|---|
| HIV Self-test Kit: Female HIV self-test kit: We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART. | 332 |
| Invitation Letter-standard of Care: Female Standard of Care: In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART. | 168 |
| HIV Self-test Kit: Male Partner HIV self-test kit: Male partners of randomized HIV-positive pregnant women who will be given oral fluid-based HIVST kits to use, along with information about HIV testing and prevention and care services. Men were offered confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART. | 161 |
| Invitation Letter-standard of Care: Male Partner Standard of Care: In the standard of care arm, male partners will be given invitation letters to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART. | 75 |
| Total | 736 |
Baseline characteristics
| Characteristic | Invitation Letter-standard of Care: Female | HIV Self-test Kit: Male Partner | Invitation Letter-standard of Care: Male Partner | Total | HIV Self-test Kit: Female |
|---|---|---|---|---|---|
| Age, Continuous | 27 years | 32 years | 31 years | 27 years | 26 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment Uganda | 168 participants | 161 participants | 75 participants | 736 participants | 332 participants |
| Sex: Female, Male Female | 168 Participants | 0 Participants | 0 Participants | 500 Participants | 332 Participants |
| Sex: Female, Male Male | 0 Participants | 161 Participants | 75 Participants | 236 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 332 | 2 / 168 |
| other Total, other adverse events | 5 / 332 | 1 / 168 |
| serious Total, serious adverse events | 5 / 332 | 1 / 168 |
Outcome results
Primary
Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm
Evaluate whether the secondary distribution of HIV self-tests to enrolled male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV
Time frame: Up to 12 months post-partum
Population: Overall 236 enrolled male partners tested for HIV
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Self-test Kit | Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm | 161 participants |
| Invitation Letter-standard of Care | Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm | 75 participants |
Primary
The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm
Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of PrEP if they test HIV-negative
Time frame: Up to 12 months post-partum
Population: There were 185 male partners without HIV in the two arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Self-test Kit | The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm | 72 Participants |
| Invitation Letter-standard of Care | The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm | 41 Participants |
Primary
The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm
Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of ART if they test HIV-positive.
Time frame: Up to 12 months post-partum
Population: There were 51 newly identified male partners living with HIV, between the two arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Self-test Kit | The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm | 33 Participants |
| Invitation Letter-standard of Care | The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm | 12 Participants |
Secondary
The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners
HIV-infected pregnant women and their male partners, experiences, perspectives and views on HIV self-testing evaluated by an inductive content analytic approach conducted through qualitative interviews. This does not permit quantification of numbers of persons who endorsed particular themes. The main themes reported were 1. Women's fear about delivering HIV self-testing kits to their partner particularly if they had not previously disclosed their HIV status to their partner. 2. Variable strategies used by women to introduce HIV self-testing to their male partners. 3. Range of male partner responses to receiving an HIV self-testing kit. 4. Women's confidence in ability to interpret HIV self-test results for their partners. 5. Women's strategies to persuade their partners to link to HIV care or HIV PrEP.
Time frame: Up to 12 months post-partum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Self-test Kit | The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners | 29 Participants |
| Invitation Letter-standard of Care | The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners | 30 Participants |
Secondary
Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing
Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with effective post-partum viral suppression among HIV-infected Uganda women.
Time frame: Up to 12 months post-partum
Population: There were 428 women with VL available at 12 months post-partum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Self-test Kit | Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing | 239 Participants |
| Invitation Letter-standard of Care | Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing | 110 Participants |