Provision of Oral HIV Self-Test Kits Triples Uptake of HIV Testing among Male Partners of Antenatal Care Clients:

Results of a Randomized Trial in Kenya

Research discussed in this publication has been funded by the International Initiative for Impact Evaluation, Inc. (3ie). The views expressed in this article are not necessarily those of 3ie or its members.

by: Anthony Gichangi1, Eva Bazant1, Stephen Mutwiwa1, Rosemary Njogu1, Jonesmus Wambua1, Tom Marwa1, Mildred Mudany1, and Jeffrey Korte2

affiliate: 1Jhpiego; 2Medical University of South Carolina

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Backgroundnn HIV prevalence in Kenya is 5.6% among

persons aged 15–64 years, with women having higher rates than men (6.9% vs. 4.4%) (Kenya AIDS Indicator Survey [KAIS] 2012).

nn Up to 6.5% of Kenya’s pregnant women are living with HIV/AIDS.

nn Among HIV-negative pregnant women, 1.3% report having a partner who is HIV-positive.

nn Many (42.2%) pregnant women do not know their partner’s status.

nn Only 6% of partners of antenatal care (ANC) clients in Eastern and Central Provinces accept HIV testing (2014).

HIV Self-Testing in Kenyann In the KAIS 2012 report, 71% of Kenyans

indicated willingness to use HIV self-test kit (74.1% of males and 67.3% of females).

nn Kenya has developed national HIV testing and counseling policies that include HIV self-testing.

nn Since 2012, the National AIDS & STI Control Programme (NASCOP), in collaboration with partners, has worked to answer key pertinent questions on self-testing.

nn Currently, guidelines are being developed to operationalize HIV self-testing.

Oral HIV Self-Testingnn The self-test’s ease of use, convenience/time

saving, and privacy/confidentiality give it the potential to increase access to HIV testing and awareness of status.

Goal and Primary ObjectiveGoal nn To increase HIV testing in the population of

male partners of pregnant women attending ANC clinics in order to increase HIV status awareness and reduce HIV transmission from mother to child.

Primary Objectivenn To determine if providing oral HIV self-test kits

can increase male partners’ HIV testing rates compared to providing an invitation letter for male partners to attend ANC clinics for testing.

Study Sitesnn 14 sites were selected in 5 counties in Eastern

and Central Kenya.nn The site selection was based on the number of

ANC clients reported in 2014. nn The sites were picked from a list of sites that

the APHIAPLUS KAMILI project, funded by the U.S. Agency for International Development, was supporting.

nn The study recruited women who were attending the first ANC visit of their current pregnancy and their partners.

Inclusion and Exclusion CriteriaInclusion criteria for women 1. First ANC visit in this pregnancy

2. Age 18+Exclusion criteria for women 1. No current male partner/does not

have at least weekly contact with partner

2. Woman reports that her partner is HIV-positive

3. Woman reports that her partner has tested within last 3 months

4. Woman is concerned for her safety or feels at risk of gender-based violence (GBV) if she asks her partner to self-test, or woman currently does not feel safe enough at home to encourage HIV testing (see the GBV screening tool)

Inclusion criteria for men 1. Male partner of the ANC client enrolled into the study

2. Has weekly contact with the woman3. Cognitive abilities to respond to the

survey questionsExclusion criteria for men 1. Unwilling to participate in the study

Study Design

Methodology: ANC Client Recruitmentnn Client was identified by the service provider

and referred to the research nurse for consent and interview.

nn Client was randomized into one of the three study arms using a concealed randomization envelope.

nn Research nurse demonstrated to the client in the self-testing arm of the study how to use a self-test kit, including how to read the results.

nn Client was also counseled on how to handle their partners in case the results were positive.

nn Client was provided with instructional materials and two oral self-test kits.

nn Other clients were given their specific invitation cards to take to their partners.

Methodology: Data Collection and Follow-Upnn Open Data Kit (ODK) software was used to

collect quantitative data electronically with tablets.

nn Data were uploaded weekly and regularly monitored for errors.

nn WhatsApp social media was used as a forum for interactive group discussions among the nurses and supervisors.

nn In-person follow-up was conducted for women and their partners.

nn Data analysis was conducted using the R and Stata software. Determinants of HIV testing were modeled using logistic regression.

Qualitative Datann Qualitative data were collected at the end of the

study to investigate the drivers and barriers to HIV testing among the male partners using focus group discussions (FGDs).

nn The FGDs were held only for the study group that received the oral HIV self-test kits.

nn FGDs were held in all five counties where the study was conducted.

Summary of the Recruitment and Follow-UpTarget

Sample SizeControl 1 N = 475

Control 2 N = 475

Intervention N = 475

Total 1,425

No. of women recruited

471 (99%) 467 (98%) 472 (99%) 1,410 (99%)

No. of women followed up

408 (87%) 387 (83%) 422 (89%) 1,217 (86%)

No. of men recruited 375 (80%) 362 (78%) 396 (84%) 1,133 (77%)

Complete woman/man pairs

366 (77%) 352 (75%) 389 (82%) 1,107 (78%)

Characteristics of ANC Clients Recruitednn 1,410 ANC clients were recruited into the study:

471 in control group 1, 467 in control group 2, and 472 in the intervention arm.

nn Client characteristics:nn The majority (91%) were between the ages of

18 and 34, with a median age of 25 years (IQR: 22–30).

nn 56% had at most a primary level of education.nn 87% were married, 11% were cohabitating,

and 94% were living together during the study period.

nn 51% were unemployed.nn 77% were Protestants.nn 93% reported they were ever tested for HIV and

63% reported they were ever tested together with their partner.

nn The characteristics were relatively balanced between the three study groups.

Characteristics of Male Partners Recruitednn 1,133 male partners were recruited into the

study: 375 in control group 1, 362 in control group 2, and 396 in the intervention arm.

nn Client characteristics:nn 72% were between the ages of 18 and 34; the

median age was 31 years (IQR: 28–35).nn 66% had at least a secondary level of

education.nn 89% were married, 11% were cohabitating,

and 94% were living together during the study period.

nn 49% were unemployed and 43% were self-employed.

nn 66% were Protestants.nn 87% reported they were ever tested for HIV.

nn Men in the intervention group were more educated than those in the other groups.

Men’s Self-Reported HIV Testing

Woman Reported Her Partner Tested

Couple TestingControl 1 N = 375

Control 2 N = 362

Intervention N = 396

Male partner’s self-reported testing with female partner 106 (28%) 133 (37%) 323 (82%)

Male partner’s self-reported testing with female partner or alone

106 (28%) 133 (37%) 327 (83%)

Agreement between Female and Partner

Study Arm

Female partner reported she

knows the partner tested

for HIV

Kappa

Control 1 (N = 105)

Male partner reported testing

for HIV

97 (94.2%) 0.90 (0.86–0.95) P-value < 0.001

Control 2 (N = 132) 115 (87.1%) 0.87 (0.81–0.92)

P-value < 0.001Intervention (N = 318) 309 (97.4%) 0.84 (0.77–0.91)

P-value < 0.001

Location of HIV TestingControl 1 N = 106

Control 2 N = 133

Intervention N = 321*

Clinic/voluntary counseling and testing (VCT) centers

105 (99%) 130 (98%) 43 (13%)

Home 1 (1%) 3 (2%) 278 (87%)

* Seven male partners had missing information on location of HIV testing.

Determinants of HIV Testing: Control Group 1

Determinants of HIV Testing: Control Group 2

Determinants of HIV Testing: Intervention Group

Usability of the Oral Self-Test Kit

What Are the Barriers to HIV Testing among Male Partners of ANC Clients in Kenya?nn Theme 1: Stigma, fear, and misinformation

about HIV in the community“Others think that it is something shameful.”

nn Theme 2: Male partners dismissive of women asking them to take the test

“My husband just laughs and thinks that I am foolish.”

nn Theme 3: Access barriers for men: Income, workload and distance

“In the communities, there are those people who live far away from the hospitals. When people are far away, they will not want to go and take those kits.”

What are the Drivers of HIV Testing among Male Partners of ANC Clients in Kenya?nn Theme 1: Importance of privacy surrounding

the HIV test“He may fear to go to the nearby clinic because maybe the doctor that you will get there, lives in your area or he knows you. Yes you are told that there is privacy, but how sure are you that he is not going to share with somebody else?”

nn Theme 2: Testing at home together is a driver of success

“Between the two processes, at home and at the hospital, it is easier to do it at home because if both of you are given, you are both going to test yourself together.”

Discussionnn There was a very high HIV testing rate where the

ANC mothers were provided with the self-test kits. nn Wealth and education were the primary

determinants of HIV testing in all three groups.nn Counseling before provision of the HIV

self-test kit is very important to increase uptake and reduce unwanted events (e.g., GBV).

nn HIV self-testing in the ANC context has the potential to increase access to testing among males and reduce mother-to-child transmission of HIV.

nn Policy implication: Guidelines for prevention of mother-to-child transmission of HIV should include self-testing as an option for male partners of ANC clients.

0

20%

40%

60%

80%

100%

28%37%

83%

Control 1 Control 2 Intervention**About half of the men in the intervention arm reported taking an HIV confirmatory test at a health facility.

P-value 0.01

P-value <0.001

0

20%

40%

60%

80%

100%

28%37%

79%

Control 1 Control 2 Intervention

P-value 0.01

P-value <0.001

Primary Secondary Lowest SecondLowest

SecondHighest

Highest

Education Wealth Index

22%

34%

51%

39%

14% 13%

100%

80%

60%

40%

20%

0

Primary Lowest SecondLowest

SecondHighest

Highest

26%

45% 45% 46%38%

20%

100%

80%

60%

40%

20%

0

Education Wealth Index

Secondary

SecondaryPrimary Lowest SecondLowest

SecondHighest

Highest

76%85% 89%

84%76% 78%

100%

80%

60%

40%

20%

0

Education Wealth Index

Kenya

Instructions Taking sample Reading theresults

83% 81% 79%89%

84%92%

Women Men

100%

80%

60%

40%

20%

0

Very

eas

y

Study sitesStudy counties