An interventional study of Enhanced Couple HIV Testing and Counseling in Hiv, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Malawi. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Women with recent HIV infections enrolled in this trial will be compared against a cohort of 350 HIV-uninfected women to explore predictors of HIV acquisition in pregnancy in Malawi.
In sub-Saharan Africa, engaging HIV-infected men in HIV care and treatment and engaging HIV-uninfected men in prevention has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors. They are less likely to seek HIV testing and counseling (HTC), initiate combination antiretroviral therapy (cART), and be retained in cART care. Poor care-seeking has resulted in a lower prevalence of viral suppression and earlier mortality. Additionally, men rarely engage in the antenatal care-seeking of their female sexual partners, leading to worse maternal and infant outcomes. This low level of engagement has been noted in Malawi's Option B+ prevention of mother to child transmission (PMTCT) program, and has been a critical barrier to female Option B+ uptake and retention, and a missed opportunity for engaging men.
There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address all of these challenges: poor male engagement in the HIV continuum of care, low male adoption of biomedical HIV prevention approaches, sub-optimal female engagement in the continuum of care, and poor or uncertain infant outcomes. Our team has designed a couples-based intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Results from this study are expected to inform how best to address family outcomes in an Option B+ program.
This study has the following aims described below:
Aim 1: Determine whether the couple-based intervention increases new HIV-positive diagnoses among HIV-infected male sex partners, helps HIV-infected men engage and remain in care, and contributes to male viral suppression compared to individual standard of care. The investigators will compare the couple-based intervention to standard of care for increasing the proportion of men who are aware of being HIV-infected, the proportion of these men who initiate and remain in cART care, and the proportion of these men with viral suppression at one year.
Aim 2: Determine whether the couple-based intervention identifies HIV-discordant couples and decreases the likelihood of male exposure to HIV compared to individual standard of care. The investigators will compare the intervention to standard of care for increasing the number of men with non-HIV exposure from their female partner through consistent condom use, viral suppression, abstinence, or a combination of these methods over one year.
Aim 3: Determine whether the couple-based intervention improves female cART retention and viral suppression compared to individual standard of care. The investigators will compare the intervention to standard of care for female cART retention and viral suppression at one year.
Aim 4: Determine whether the couple-based intervention improves infant early infant diagnosis uptake compared to individual standard of care. Explore uptake of early infant diagnosis and rates of mother-to-child transmission and child survival in the two intervention arms.
Aim 5: Develop an in-depth understanding of HIV transmission dynamics in Lilongwe. Using the biomarkers and behavioral survey, we will seek to understand transmission timing, direction, and context in Lilongwe. We will compare women with recent HIV infection to a population of HIV-uninfected controls (n=350) to understand predictors of HIV acquisition in pregnancy in Malawi.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 1,116 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria (-infected Women):
Part of a heterosexual relationship for >3 months
Inclusion Criteria (Male Partners of HIV-infected women)
In a relationship with the female partner for >3 months
Inclusion Criteria (HIV-uninfected Women):
Part of a heterosexual relationship for >3 months
Exclusion Criteria (all Women and Male Partners):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV-infected pregnant women enrolled in the individual arm of the study will receive Standard of Care Option B+ procedures.
In addition to receiving standard of care procedures, HIV-infected pregnant women in the couple arm will be provided with an intervention aimed at recruiting their male partners, providing enhanced couple counseling and testing, engaging their male partners in their care, and supporting male partners to receive care and treatment services.
Behavioral: Enhanced Couple HIV Testing and Counseling
HIV-uninfected pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.
Participants are provided study-specific partner referral cards and encouraged to bring male partners to antenatal care for a male engagement intervention. Those who do not present on their own are then traced. Couples will receive three enhanced couple counseling sessions that include: pre-test counseling, return of joint results, and post-test counseling. HIV-infected men will be able to initiate cART at the antenatal clinic and the couple will be offered condoms from the HTC counselor. Between sessions, couple members can pick up condoms and cART for one another.
Also known as: male engagement intervention
Number of Women Retained in Care
Women who presented at 12 months and reported taking at least one dose of ART in the last seven days
Time frame: 12 months
Number of Women With Viral Suppression
Women who presented at 12 months with a viral load \<1000 copies/mL
Time frame: 12 months
Number of HIV-positive Male Partners Aware of Their HIV-positive Status
HIV-positive male partners who presented at 12 months and reported knowing they were HIV-positive prior to receiving the results of the HIV test conducted at the 12 month study visit
Time frame: 12 months
Number of HIV-positive Male Partners Retained in Care
HIV-positive male partners who presented at 12 months and reported taking at least one dose of ART in the last seven days
Time frame: 12 months
Number of HIV-positive Male Partners With Viral Suppression
HIV-positive male partners who presented at 12 months with a viral load \<1000 copies/mL
Time frame: 12 months
Number of HIV-negative Men Without HIV Exposure From Their Primary Partner
HIV-negative men with a) consistent condom use in the last six months or b) a suppressed female partner or c) abstinence with primary partner
Time frame: 12 months
Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis
HIV-positive female participants who reported a live birth and uptake of early infant diagnosis
Time frame: 12 months
Predictors of Recent HIV Infection
Risk factor analysis to identify predictors of recent HIV infection among pregnant women
Time frame: At the day of female consent
| Milestone | Individual (HIV+ Women) | Couple (HIV+ Women) | Male Partners of Women in Individual | Male Partners of Women in Couple | Control Population (HIV- Women) |
|---|---|---|---|---|---|
| Started | 250 | 250 | 98 | 168 | 350 |
| Completed | 203 | 202 | 98 | 136 | 349 |
| Not completed | 47 | 48 | 0 | 32 | 1 |
Women who presented at 12 months and reported taking at least one dose of ART in the last seven days
| Participants | Individual (HIV+ Women) | Couple (HIV+ Women) |
|---|---|---|
| Number of Women Retained in Care | 160 | 164 |
Women who presented at 12 months with a viral load \<1000 copies/mL
| Participants | Individual (HIV+ Women) | Couple (HIV+ Women) |
|---|---|---|
| Number of Women With Viral Suppression | 145 | 162 |
HIV-positive male partners who presented at 12 months and reported knowing they were HIV-positive prior to receiving the results of the HIV test conducted at the 12 month study visit
| Participants | Male Partners of Women in Individual | Male Partners of Women in Couple |
|---|---|---|
| Number of HIV-positive Male Partners Aware of Their HIV-positive Status | 44 | 67 |
HIV-positive male partners who presented at 12 months and reported taking at least one dose of ART in the last seven days
| Participants | Male Partners of Women in Individual | Male Partners of Women in Couple |
|---|---|---|
| Number of HIV-positive Male Partners Retained in Care | 34 | 59 |
HIV-positive male partners who presented at 12 months with a viral load \<1000 copies/mL
| Participants | Male Partners of Women in Individual | Male Partners of Women in Couple |
|---|---|---|
| Number of HIV-positive Male Partners With Viral Suppression | 31 | 53 |
HIV-negative men with a) consistent condom use in the last six months or b) a suppressed female partner or c) abstinence with primary partner
| Participants | Male Partners of Women in Individual | Male Partners of Women in Couple |
|---|---|---|
| Number of HIV-negative Men Without HIV Exposure From Their Primary Partner | 39 | 59 |
HIV-positive female participants who reported a live birth and uptake of early infant diagnosis
| Participants | Individual (HIV+ Women) | Couple (HIV+ Women) |
|---|---|---|
| Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis | 162 | 158 |
Risk factor analysis to identify predictors of recent HIV infection among pregnant women
| Participants | Individual and Couple HIV-positive Women | Control Population (HIV- Women) |
|---|---|---|
| Married to Primary Partner | 38 | 338 |
| Not Married to Primary Partner | 6 | 11 |
Collected over For the two groups of HIV-positive women, adverse event data were collected from the signing of the Informed Consent through 1 year afterward. For the two groups of male partners of HIV-positive women, adverse event data were collected from the signing of the Informed Consent through 1 year after consent of their partner.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individual (HIV+ Women) | 1/250 (0.4%) | 0/250 (0%) | 0/250 (0%) |
| Couple (HIV+ Women) | 1/250 (0.4%) | 0/250 (0%) | 0/250 (0%) |
| Male Partners of Women in Individual | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| Male Partners of Women in Couple | 0/168 (0%) | 0/168 (0%) | 0/168 (0%) |
| Control Population (HIV- Women) | — | — | — |
Data unreported for 6 surveys that corrupted during upload. Data unavailable for one HIV-negative woman.
| Age, Categorical(Participants) | Individual (HIV+ Women) | Couple (HIV+ Women) | Male Partners of Women in Individual | Male Partners of Women in Couple | Control Population (HIV- Women) | Total |
|---|---|---|---|---|---|---|
| <=18 years | 15 | 11 | 1 | 0 | 37 | 64 |
| Between 18 and 65 years | 231 | 238 | 97 | 167 | 312 | 1045 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Individual (HIV+ Women) | Couple (HIV+ Women) | Male Partners of Women in Individual | Male Partners of Women in Couple | Control Population (HIV- Women) | Total |
|---|---|---|---|---|---|---|
| Female | 246 | 249 | 0 | 0 | 349 | 844 |
| Male | 0 | 0 | 98 | 167 | 0 | 265 |
| Race and Ethnicity Not Collected(Participants) | Individual (HIV+ Women) | Couple (HIV+ Women) | Male Partners of Women in Individual | Male Partners of Women in Couple | Control Population (HIV- Women) | Total |
|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Individual (HIV+ Women) | Couple (HIV+ Women) | Male Partners of Women in Individual | Male Partners of Women in Couple | Control Population (HIV- Women) | Total |
|---|---|---|---|---|---|---|
| Malawi | 246 | 249 | 98 | 167 | 349 | 1109 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Jul 2020, 33 months.
Results were first posted in Jun 2021, 11 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 33 months is close to that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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